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

Model Number 417-152

Device Problem Material Separation (1562)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced to treat a lesion in the popliteal/tibioperoneal (tp) trunk.Using a spectranetics turbo elite laser atherectomy catheter, the first pass through the lesion was successful.Upon decreasing the rate of energy delivery in preparation for the second pass, the turbo elite malfunctioned.The device was removed from the patient, and attempts to re-calibrate were unsuccessful.Another 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, along with exposed and broken fibers in the area, was discovered.This event is being reported for unintended radiation exposure, potential for harm.

Manufacturer Narrative

Patient''s weight unk.Patient''s ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.Isual inspection found the outer jacket severely twisted and torn, approximately 22 inches distal to the bifurcate handle.In addition, a breach to the outer jacket, with multiple exposed and broken fibers, was discovered.Charring was observed on the broken fibers still inside the jacket.There were 14 dead fibers noted at the distal tip, and 10 noted at the proximal end.H6): based on the evaluation and investigation findings, this failure has been determined to be use related.Since there was no report of device damage pre-procedure, the failure likely occurred during use of the device.Historically, the manufacturer has noted this failure when excessive forces are applied to the device.The device then becomes twisted and the broken fibers at the area produce heat, creating a breach in the outer jacket.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.

• Brand Name: TURBO-ELITE LASER ATHERECTOMY CATHETER
• Type of Device: 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 ; 719447-246
• MDR Report Key: 17557952
• MDR Text Key: 321415783
• Report Number: 3007284006-2023-00015
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024743
• UDI-Public: (01)00813132024743(17)250405(10)FAZ23C28A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ23C28A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASAHI 0.018 GLADIUS GUIDE WIRE.; COOK MEDICAL 6F FLEXOR INTRODUCER SHEATH.; SECOND LASER CATHETER MANUFACTURER/SIZE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Age: 70 YR
• Patient Sex: Male