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

Model Number 423-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Vascular intervention case using a turbo elite laser catheter.The catheter was used for a first pass and then removed from the patient.Upon re-entry of the catheter into the patient the physician noted that laser light could be see through the sides of the catheter in multiple locations.Another turbo elite catheter was used to complete the case.No adverse effects were experienced by the patient.This event is being reported due to the potential of exposure to manufacturing materials and inadvertent exposure to laser energy.

Manufacturer Narrative

Device evaluation; there are approximately 12 fibers dead at the distal tip.The jacket has damage resulting in exposed fibers 10.25" distal of bifurcate.There are several additional wrinkles along working length.The wrinkles are indicative of heavy use and pushing along the working length.There is no indication of a failure in the manufacturing of this device.The case did not result in any patient harm and the case was completed with another catheter.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 5602219
• MDR Text Key: 44375419
• Report Number: 1721279-2016-00056
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140775
• 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,Followup,Followup,Followup
• Report Date: 04/08/2016

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: 03/13/2017
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC15D13A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/24/2017
• Supplement Dates FDA Received: 05/26/2016; 03/23/2017; 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2015
• 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