MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION 2.0 TURBO ELITE

Model Number	420-159
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384); Material Separation (1562); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No patient age, dob, or weight was available from the site.Visual and microscopic evaluation of the suspect device was completed.Reported issue confirmed.The catheter marker band missing.Under microscopic examination the epoxy tip is not deformed, clean disconnect.Conclusion codes: device was reportedly utilized in a stent, which is not approved use as the stent causes an increase in temperature which can lead to device damage.This notification is marked due this model of device being included in a field safety notice which was issued, containing safety concerns regarding off label use of this model of device being used within a stent.
Event or Problem Description
A philips representative reported that during a peripheral vascular surgery, left anterior tibial access was used.Diagnostic images were taken and showed severe left superficial femoral artery (sfa) in-stent occlusion.The 80-85% occlusions of soft plaque were found throughout the stent, with some calcium noted in the proximal section of stent.The spectranetics 2.0 turbo-elite catheter (420-159) was opened and prepped without issue.The 2.0 turbo-elite catheter (420-159) was successfully advanced to the distal part of the stent and passed smoothly.After the first pass of about 20 seconds laser time and about 30cm advancement, it was noticed that the distal tip of the laser catheter was no longer visible on the imaging.The laser was removed and the metal radiopaque ring was found to be in the popliteal artery off the wire and wedged in a side branch of the popliteal artery.The physician was unable to manipulate the metal ring with aspiration or balloon therapy.The physician decided that the metal ring was "stuck" in the popliteal side branch and that it would be left in place.They opened another 2.0 turbo-elite catheter and finished lasing the rest of the sfa stent without incident.After all devices were removed, an angiogram of the left leg was performed and found the metal ring to be in the same spot.Arterial blood flow to the lower leg was excellent.The case was concluded.

• Brand Name: 2.0 TURBO ELITE
• Common Device Name: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7879224
• Report Number: 1721279-2018-00127
• Device Sequence Number: 16663216
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: 00813132024765
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 08/20/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH18C28A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005