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

Model Number	417-156
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth, age at time of event unk.Patient gender unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.Because the device was not returned for evaluation, the cause of the reported damage could not be determined.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a lesion, location unk.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During preparation for use, a hole in the laser sheath was observed.The device was not returned; however, photos of the device showed an area of the device's tail tube that appeared kinked and slightly twisted.A red dot was present in the photo in the area of the kink, which could indicate laser light emitting from the area; however this could not be confirmed.Another device was used to complete the procedure with no reported patient harm.Based on the photos provided, this event is being reported for unintended radiation exposure, potential for harm.

• 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: 12537440
• Report Number: 1721279-2021-00178
• Device Sequence Number: 1350467
• Product Code: MCW
• UDI-Device Identifier: 00813132024741
• UDI-Public: (01)00813132024741(17)230624(10)FBG21F14A
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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
• Report Date (Section B): 08/31/2021

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: 06/24/2023
• Device Model Number: 417-156
• Device Catalogue Number: 417-156
• Device Lot Number: FBG21F14A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial 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