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

Model Number 414-151

Device Problems Material Separation (1562); Material Deformation (2976)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced to treat a moderately calcified lesion in the mid posterior tibial (pt) artery.The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.It was reported that the turbo elite device could not cross the lesion.When the device was removed from the patient, they noticed the back end of the catheter was melted and fibers exposed.Photo returned to the manufacturer confirmed the report.A.9 turbo elite device was used to complete the procedure with no reported patient harm.Based on the photos provided, this event is being reported for unintended radiation exposure, potential for harm.

Manufacturer Narrative

Patient's date of birth and age unk, patient's gender unk, patient's weight unk, patient's race/ethnicity unk, relevant tests/laboratory data unk, other relevant history unk.The device was discarded, thus no investigation could be completed.Photo provided to the manufacturer showed deformation and separation of the device's outer jacket, being held together by exposed fibers within the device.With no device evaluation possible, the cause of the failure cannot be established.

• 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: 12733605
• MDR Text Key: 283166319
• Report Number: 1721279-2021-00209
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)230504(10)FAY21D23A
• 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
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY21D23A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MPA GUIDE CATHETER MODEL/SIZE UNK; SPARTACORE 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH