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

Model Number	417-152
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable.(b)(4).The manufacturer is anticipating the return of the device for evaluation, but has not received it at this time.
Event or Problem Description
A peripheral atherectomy procedure commenced to provide treatment to 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 within the patient, red light was seen emitting from the side of the catheter.It was reported there was a crack in the catheter; however, the physician was unsure of the efficacy of the device.The turbo elite device was reportedly used to complete the procedure with no reported patient harm.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.The manufacturer is anticipating return of the turbo elite catheter for evaluation, but has not received it at this time.
Additional Manufacturer Narrative
D9): the device was received by the manufacturer on 24 may 2021.H6): in the initial mdr, hecc code 4565 was used, from the information the manufacturer received in the initial complaint report.However, after the device evaluation and investigation were completed, this code has been changed to 4582 (see device evaluation below).H6): added codes: 814, 772, 4582, 2199, 10, 3251, 3211, 19, and 61.Device evaluation: the turbo elite device was received by the manufacturer on 24 may 2021 and was evaluated on 03 june 2021 by a cross functional team.Red light was observed at 98cm from the device's distal tip.The red light was seen from the area in which broken fibers were present under the device's outer jacket.The device's outer jacket was slightly charred but was not melted.There was no breach in the device's outer jacket.The device's outer jacket was removed to determine the number of broken fibers; there were three broken fibers in this area and the fibers were also charred slightly at their tip.It is likely that the fibers were broken and then during use of the laser, the laser energy charred the outer jacket slightly but did not melt through the jacket.This failure has been determined to be use related.However, there was no exposure to manufacturing materials or unintended radiation exposure.As a result, this event is no longer reportable to the fda.

• 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: 11807090
• Report Number: 1721279-2021-00086
• Device Sequence Number: 3515036
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)230203(10)FAZ21A20A
• 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): 04/14/2021

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: 02/03/2023
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ21A20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other