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

Model Number 414-151

Device Problem Melted (1385)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the patient''s proximal superficial femoral artery (sfa).The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.During the procedure, the catheter started smoking; the guide wire became stuck in the turbo elite catheter as well and the entire system was removed.It was noted that the the device''s tip had melted.The case was aborted, and the patient has been scheduled later to attempt a retrograde popliteal approach.There was no reported patient harm.This report captures the turbo elite device which was damaged during the procedure, causing unintended radiation exposure, potential for harm.

Manufacturer Narrative

Patient''s date of birth unk.The device was returned to the manufacturer on 15 mar 2022.Device evaluation: the device was returned and evaluated by a cross functional team.The outer jacket of the device was melted, twisted, and wrinkled just distal to the bifurcate strain relief on the working length.Broken fibers and a breach to the device''s outer jacket were observed in this area.The outer jacket of the device became twisted, indicative that excessive force was applied to the device.The twists and wrinkles caused broken fibers; the broken fibers created laser energy and ultimately melted the outer jacket, resulting in the breach.This has been determined to be a use related failure.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Type of Device: 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: 13865966
• MDR Text Key: 290456731
• Report Number: 1721279-2022-00061
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)231013(10)FAY21K05A
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2023
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY21K05A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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: COOK MEDICAL 6F INTRODUCER SHEATH; SPARTACORE 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American