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

Model Number 410-154

Device Problem Material Separation (1562)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 09/20/2023

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced, accessing the lesion from the femoral and brachial arteries, using a contralateral approach (lesion on opposite side of the body from the access site).A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.When removing the turbo-elite from the body, it appeared stuck on the introducer sheath, which was positioned across the curve in the vasculature, near the femoral site.However, after a few seconds of pulling, the device was successfully removed and appeared intact.The procedure was completed with no reported patient harm.Based upon the device evaluation, a breach in the outer jacket, along with exposed fibers in the area, was discovered.This event is being reported for unintended radiation exposure, potential for harm.

Manufacturer Narrative

A2): patient''s date of birth, age unk.A3): patient''s gender unk.A4): patient''s weight unk.A5a./5b.): patient''s ethnicity/race unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.H3): visual inspection of the turbo-elite found a breach to the outer jacket, 6.5 cm from the distal tip.The outer jacket and inner lumen were wrinkled and fractured at the area of the breach, pulled away approximately 2 cm, exposing the fibers in the area.No broken fibers were detected.H6): based on the device evaluation and investigation, the cause of the damage cannot be established.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: 18144903
• MDR Text Key: 328391451
• Report Number: 3007284006-2023-00064
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024703
• UDI-Public: (01)00813132024703(17)250613(10)FBE23E25A
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410-154
• Device Catalogue Number: 410-154
• Device Lot Number: FBE23E25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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: GUIDE WIRE MANUFACTURER/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM