MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER; TURBO ELITE

Model Number	410-152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The spectranetics turbo-elite device and the guidewire were discarded following the case.Therefore, device evaluation is not possible.This report is being submitted as there is an allegation that the turbo-elite device may have contributed to the coating coming off the guidewire.However, per engineering evaluation of the available data, it is very unlikely the turbo-elite device could scrape off the coating of the guidewire, as it does not have a metal inner lumen.Furthermore, it is unknown how the turbo-elite device could possibly ablate the material off the guidewire in such a short ablation time (2 seconds).
Event or Problem Description
A philips representative reported that a peripheral atherectomy procedure was performed to resolve a de novo chronic total occlusion in the patient's left anterior tibial artery.The physician used a step by step method to advance through the vessel from a femoral access point, utilizing a spectranetics turbo-elite laser atherectomy catheter 410-152 over a v14 controlwire (boston scientific) hydrophilic guide wire.Upon reaching the tip of the guide wire, part of the wire coating was shaved off within approximately 2 seconds of lasing to cross the lesion.The tibio peroneal trunk was treated prior to this vessel and successfully opened resulting in good outflow for the patient.The procedure was stopped at this point and the patient was discharged per normal procedure.There was no change in outflow to the anterior tibial artery.

• Brand Name: SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8016114
• Report Number: 1721279-2018-00154
• Device Sequence Number: 1382328
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: 00813132024697
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018
• 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: 08/14/2020
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD18H06A
• Was Device Available for Evaluation?: No
• 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: 10/08/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRANETICS CVX-300 EXCIMER LASER
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 91
• Date Report Sent to FDA: 01/01/2005