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

Model Number 410-152

Device Problems Material Puncture/Hole (1504); Material Twisted/Bent (2981)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced to treat a plaque lesion in the mid anterior tibial (at) vessel.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.When they were going to insert the turbo elite device for a second run through the lesion, they noticed the tip of the catheter was melted.Another turbo elite device was used to complete the procedure with no reported patient harm.Photos of the returned device reveal a breach in the device's outer jacket with exposed, broken fibers.Based on the photos received by the manufacturer, this event is being reported for unintended radiation exposure, potential for harm.

Manufacturer Narrative

Patient's weight unk.Relevant tests/laboratory data unk.Other relevant history unk.Photos have been taken of the returned device, but evaluation and investigation pending.Supplemental mdr will be submitted after evaluation and investigation are completed.

Manufacturer Narrative

G3): device evaluation and investigation were completed on 05 nov 2021.H6): device evaluation: the device was returned and evaluated by a cross functional team.A breach to the outer jacket and broken fibers were seen approximately 1.5 in from the device''s distal tip.The device''s outer jacket was twisted 0.5 in from the device''s distal tip, but no breach or broken fibers were seen in this area.The twist and breach to the outer jacket likely occurred during removal of the device before attempting a second pass through the lesion.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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12694434
• MDR Text Key: 282712669
• Report Number: 1721279-2021-00196
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)230709(10)FBD21F29A
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD21F29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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: 2ND TURBO ELITE DEVICE TO COMPLETE CASE; ABBOTT 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic