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

Model Number 410-152

Device Problem Material Perforation (2205)

Patient Problems Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the facility.The device was evaluated 26sep2019 by cross-functional team.A breach in the catheter jacket was observed 21.5 inches distal from the bifurcate.Broken laser fibers were confirmed.The jacket looked to be slightly twisted or kinked.Looking at the distal tip, broken and burned fibers were visible as well as fiber and epoxy erosion.Unable to determine the cause of the breach.

Event Description

A peripheral atherectomy procedure commenced to treat a fibrous lesion in the posterior tibial vessel.A spectranetics turbo-elite laser atherectomy catheter was utilized in the patient.It was found that the turbo-elite had a hole in the side of catheter, the laser fibers were exposed.A second turbo-elite was used to complete the procedure.No patient injury occurred.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

• Brand Name: SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9131735
• MDR Text Key: 160557128
• Report Number: 1721279-2019-00165
• Device Sequence Number: 1
• Product Code: MCW
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD19G03A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2019
• 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
• Patient Outcome(s): Other