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

Model Number	417-152
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is anticipating the return of the device for evaluation, but has not received it at this time.(b)(4).
Event or Problem Description
It was reported to a philips representative on 09 june 2021 that preparations were commencing for a peripheral atherectomy procedure to begin on (b)(6) 2021.It was reported that a spectranetics turbo elite laser atherectomy catheter was being calibrated.During calibration, the catheter reportedly became so hot that it made a hole in the technician's glove, but required no medical attention.This event is being conservatively reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation, based upon the description provided in the complaint.
Additional Manufacturer Narrative
G3): last good faith effort completed on 26 july 2021.H3): the manufacturer was originally informed the device was being returned for evaluation.However, the device has not been returned despite requests from the manufacturer, so no investigation could be completed.This supplemental report is being submitted to correct the event to device not returned.H6): added codes 4755, 4114, 3221, 4315.

• 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: 12096315
• Report Number: 1721279-2021-00123
• Device Sequence Number: 20021575
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)220814(10)FAZ20H10A
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 08/14/2022
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ20H10A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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
• Patient Age: 28 YR
• Patient Weight: 63