MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER

Model Number 414-151

Device Problem Melted (1385)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 07/30/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.Upon visual inspection, damage to the outer jacket of the device was identified 4.75 inches from the bifurcate.The jacket was breached.Additionally, exposed laser fibers were visible at the breach.

Event Description

It was reported that during a vascular intervention procedure, the physician identified an area of the turbo elite catheter in which the outer jacket was compromised.Reportedly this was identified while the physician was performing his final lasing train, and laser light was visible through the catheter jacket.The physician then attempted removal of the device, but the outer jacket had melted to the guidewire.The wire and device were removed together, and the procedure was successfully completed by crossing the lesion with another wire and completing the intervention.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 ABLATION CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6822535
• MDR Text Key: 83876625
• Report Number: 1721279-2017-00179
• Device Sequence Number: 1
• Product Code: MCW
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2017

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: Physician
• Device Expiration Date: 06/08/2019
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY17F05A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2017
• 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