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

Model Number	410-152
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable.The component code and health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter component codes nd heic code.The device was returned to the manufacturer and evaluated by a cross functional team on 22 april 2021.Damage was observed approximately 112 cm from distal tip.The damage consisted of a kink and a breach in the jacket with fibers exposed.Additional damage observed 114 cm from distal tip.This damage consisted of a kink without a breach in the jacket or fibers exposed.The kink located at the 112cm had a hole which appeared to be melted, likely by laser energy where the broken fibers were located.The outer jacket was then removed and fibers appear burned/charred due to thermal energy being emitted where the broken fibers were detected, and a few additional broken fibers were discovered in this area as well.Likely the fibers were kinked and then while lasing, the broken fibers caused the adjacent fibers to burn and the device''s outer jacket to melt.This has been determined to be a use related failure.
Event or Problem Description
A peripheral atherectomy procedure commenced on 10 feb 2021 to treat an occluded distal segment of the patient''s superficial femoral artery (sfa).The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During use in the procedure, it was reported that the device was frayed with wires sticking out.A new device was opened and the procedure was completed with no reported patient harm.In subsequent conversations with the philips representative who was present in the procedure, he reported that no wires were sticking out of the device, the shaft of the catheter appeared white in color, and approximately mid way up the working length of the device, red light was seen through the outer jacket.There were no holes or breaches seen in the device, so the complaint was deemed not reportable at that time.However, upon return of the device to the manufacturer for evaluation, it has become a reportable event.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.The device evaluation is captured.
Additional Manufacturer Narrative
H6): added codes: 772, 814, and 2199.

• 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: 11845791
• Report Number: 1721279-2021-00092
• Device Sequence Number: 17111078
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)230106(10)FBD20M20A
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 01/06/2023
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD20M20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/14/2021
• 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: 0.014 GUIDE WIRE MANUFACTURER UNKNOWN; 6F INTRODUCER SHEATH MANUFACTURER UNKNOWN; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other