The FDA sent a warning letter last month to Spectranetics (NSDQ:SPNC), flagging the company for problems with its GlideLight and SLS II lead extraction sheaths made in Colorado.
The FDA inspected Spectranetics’ Colorado Springs facility from the end of November 2015 through January 21, issuing a Form 483 warning based on problems found during the inspection. Spectranetics responded in February and March, but according to the May 26 warning the federal safety watchdog published last week, Spectranetics failed to adequately address some of the violations.
The most serious issue flagged in the heavily redacted warning letter involve an unspecified number of deaths reported with the devices since August 2014. The FDA said Spectranetics failed to adequately document its risk analysis and found problems with its corrective and preventive action plan.
“There have been at least [redacted] deaths reported with the GlideLight Laser Sheath/SLS devices since August 2014. These were evaluated against the applicable Risk Assessment Library, and the hazards listed within the complaints were related to [redacted]. Although there have been at least [redacted] deaths and multiple complaints as described, the highest applicable risk severity rating is listed in the risk analysis as level [redacted] instead of level [redacted],” Denver district director LaTonya Mitchell wrote in the warning letter. “We reviewed your responses and found they are inadequate. Some specific examples include the following, and these are not an all-inclusive list of our concerns with your response. Your 2/10/16 response provided an updated risk analysis document with the severity changed to [redacted] deaths mentioned within the 483. This update changed the [redacted] multiple examples. There is no discussion of the investigation or other steps that will follow to ensure these risks will be mitigated as appropriate.”
The FDA’s Manufacturer and User Facility Device Experience database shows 7 adverse event reports, including 2 deaths, for the SLS II device since August 2014. The MAUDE database also shows 139 adverse event reports for the GlideLight device, including 46 deaths, over that span. The database shows 254 total adverse events for SLS II, including 91 deaths, and 323 reports including 116 deaths for GlideLight.
Spectranetics also failed to validate a process used to manufacture part of the outer jackets subassembly for both devices, the FDA said.
“Complaints have been reported for failures such as cracks, splits, damage to the outer jacket and / or sparks and visible laser light through the outer jacket,” Mitchell wrote, noting that the company also failed to adequately document CAPA procedures and to perform quality re-audits, among other violations. Further inspections are in store to “verify the implementation and effectiveness of your corrective actions during our next inspection,” Mitchell wrote.
Spectranetics said in an SEC filing that it’s “working diligently to fully remediate the FDA’s observations regarding the Colorado Springs facility.”
“The company will continue manufacturing and shipping disposable product from the Colorado Springs facility, and we do not anticipate that customer orders will be impacted while the company works to resolve the FDA’s concerns. The warning letter states that, until the violations have been corrected, pre-market approval applications for devices to which the quality system regulation deviations are reasonably related will not be approved. The company presently has no such applications before the FDA,” Spectranetics said.
SPNC shares were up 1.5% to $19.45 apiece today in mid-afternoon trading.
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