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

Model Number	417-152
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for investigation.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a lesion in the proximal superficial femoral artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During the procedure, it was reported that the housing of the catheter was broken; when they inserted the catheter they could see red light emitting through the middle of the catheter.The procedure was completed with a second turbo elite device with no reported patient harm.This report captures the turbo elite which was reported damaged during use and resulted in unintended radiation exposure with potential for harm.
Additional Manufacturer Narrative
The device was returned to the manufacturer on 14 sept 2021.The device investigation was completed on 16 sept 2021.The device was returned and evaluated by a cross functional team.Wrinkles were seen on the device''s outer jacket, 45.75in from the distal tip.Dead fibers and a breach to the outer jacket were seen in the area of the wrinkles.8-9 dead fibers were seen at both the distal tip and the proximal coupler.Likely, the device''s outer jacket became caught on an unknown structure, causing the wrinkles in and a breach to the outer jacket.This failure has been determined to be use related.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12339190
• Report Number: 1721279-2021-00154
• Device Sequence Number: 4542680
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)230512(10)FAZ21E04A
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2023
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ21E04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/27/2021
• 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: 2ND TURBO ELITE LASER ATHERECTOMY CATHETER; BOSTON SCIENTIFIC 0.014 GUIDE WIRE; COOK MEDICAL 6F INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM