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

Model Number	410-152
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3): visual inspection found a kink on the working length, approximately 110 cm from the distal tip, with epoxy ablation and charring noted (indicative of heavy use).On the working length, a breach to the outer jacket was observed, with charred and exposed fibers.During functional testing, an 0.014" laboratory guide wire advanced, loading from both the proximal and distal ends, with minimal resistance.H6): based on the device evaluation and investigation, the reported failure (wire could not be advanced over the laser catheter) could not be replicated.The cause of the breach and the exposed fibers could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a moderately calcified plaque lesion in the proximal popliteal artery.A spectranetics turbo elite laser atherectomy catheter was used to treat the patient.During use, it was reported that the guide wire could not be advanced over the laser catheter.The device was removed and a new laser catheter was used to complete the procedure with no reported patient harm.However, upon return of the device for evaluation, a breach in the outer jacket was discovered, with exposed fibers in the area.This event is being reported for unintended radiation exposure, potential for harm.

• Brand Name: TURBO-ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 17558179
• Report Number: 3007284006-2023-00016
• Device Sequence Number: 20034174
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)250214(10)FBD23B02A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2023

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: 02/14/2025
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD23B02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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: RUNTHROUGH 0.014 300 CM GUIDE WIRE MFR UNK.; SECOND LASER CATHETER MANUFACTURER/SIZE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; TERUMO 5F DESTINATION INTRODUCER SHEATH.
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic
• Patient Race: White