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

Model Number	423-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable; facility declined to provide.Relevant tests/laboratory data not available from facility.Other relevant history not available from facility.The manufacturer anticipates return of the turbo elite device for evaluation, but has not received it at this time.
Event or Problem Description
It was reported that during treatment to a soft tissue lesion in the patient''s superficial femoral artery (sfa) with a spectranetics turbo elite laser atherectomy catheter, the physician reported to a philips (b)(4) representative that the "fiber was disconnected".It was clarified that red light was seen through the catheter.The procedure was completed with another of the same device and the patient survived the procedure.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
Event or Problem Description
This event is no longer reportable for potential exposure to manufacturing materials and unintended radiation exposure.Per the returned device analysis, no breach in the device''s outer jacket was detected.This event did not result in patient harm nor would it cause or contribute to patient harm with recurrence.
Additional Manufacturer Narrative
B5): this event is no longer reportable per the device analysis results.D9): the device was returned to the manufacturer on 20 july 2021.H3): the device was evaluated by the manufacturer.H6): in the initial mdr, hecc code 4565 was used, based on the information the manufacturer received in the initial complaint report.However, after the device evaluation and investigation were completed, this code has been corrected to 4582 (see device evaluation below).H6): added component code 772.Code 814 remains applicable for the event.H6): added codes 4582, 10, 3252, and 67.Device evaluation: the device was returned to the manufacturer and evaluated on 29 july 2021 by a cross functional team.While the device was plugged into simulated laser light, red light was seen through the outer jacket 2cm from the distal tip, indicating broken fibers were present in that area.However, no kink was seen in the area and there was no breach to the outer jacket.The device''s distal tip had 2 dead fibers, which is within specifications for the release of the device for distribution.It cannot be determined how the fibers were broken.

• 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: 12158927
• Report Number: 1721279-2021-00126
• Device Sequence Number: 19846779
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)221123(10)FBC20L13A
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 11/23/2022
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC20L13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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: 7F INTRODUCER SHEATH MANUFACTURER UNK; SECOND SPECTRANETICS TURBO ELITE LASER CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; 7F INTRODUCER SHEATH MANUFACTURER UNK; SECOND SPECTRANETICS TURBO ELITE LASER CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM