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

Model Number	417-152
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable.Attempts to obtain the information have not been successful.Relevant tests/laboratory data unavailable.Attempts to obtain the information have not been successful.The device was discarded, thus no investigation could be completed.
Event or Problem Description
It was reported that on (b)(6) 2021 a peripheral atherectomy procedure commenced.It was reported that the physician was in a tortuous vessel using a spectranetics turbo elite laser atherectomy catheter to treat the patient.During the procedure, the device's distal marker band detached onto the guide wire.The marker band was able to be retrieved successfully and there was no reported patient harm.The device is not being returned for evaluation.This report is being submitted due to the potential for injury with recurrence.

• 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: 11976193
• Report Number: 1721279-2021-00107
• Device Sequence Number: 17198343
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)230317(10)FAZ21B25A
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 03/17/2023
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ21B25A
• 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: 05/14/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1