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

Model Number	420-006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned, thus no investigation could be completed.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a lesion in the patient''s mid superficial femoral artery (sfa).The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.During preparation for use, the technician was calibrating the catheter and noticed a red light on the side of the device''s tip.A new turbo elite device of the same model was used, and the procedure was completed with no reported patient harm.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
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14087707
• Report Number: 1721279-2022-00065
• Device Sequence Number: 5288835
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)240103(10)FBA21M10A
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

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: 01/03/2024
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA21M10A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC: THRUWAY 0.014 GUIDE WIRE; COOK MEDICAL: 6F FLEXOR INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White