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

Model Number 420-159

Device Problem Break (1069)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

Patient's date of birth unavailable.Patient''s weight unavailable.Patient's ethnicity/race unavailable.Relevant tests/laboratory data unavailable.Other relevant history unavailable.The manufacturer is anticipating the return of the device for evaluation, but has not received it at this time.

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 to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.After the physician had used the turbo elite device in the patient and was removing the device, he noticed the "inside components of the catheter were coming out of the catheter".A balloon was used to finish the procedure, and there was no reported patient harm.This event is being submitted to capture the turbo elite which was found damaged after use and resulted in unintended radiation exposure with potential for harm.

Manufacturer Narrative

D9): the device was returned to the manufacturer on 10 aug 2021.G3): the device was evaluated 12 aug 2021.H3): device evaluation: the device was returned and evaluated by a cross functional team.An obvious breach to the outer jacket was seen 3cm from the device''s distal tip and extended to the guide wire port.The device''s inner lumen and fibers were exposed but no dead fibers were seen.Using an 0.14 guide wire threaded through the distal end of the device, the guide wire exited out of the inner lumen in the area of the breach.Likely, during removal of the device, the guide wire was pulled laterally away from the device which caused the outer jacket to tear.This failure mode has been determined to be use related.

• 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
• MDR Report Key: 12242946
• MDR Text Key: 264325231
• Report Number: 1721279-2021-00143
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)230422(0)FBH21D12A
• Combination Product (y/n): Y
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH21D12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON MANUFACTURER UNK.; COOK MEDICAL 6F INTRODUCER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; TERUMO RUNTHROUGH 0.014 GUIDE WIRE.
• Patient Age: 85 YR