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

Model Number 417-152

Device Problems Bent (1059); Break (1069); Kinked (1339); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unavailable.Facility personnel declined to provide this information.Udi field not sufficient to hold all digits, should read: (b)(4).Device evaluation: a breach to the outer jacket was identified ~5/8 inch from the bifurcate.Multiple sections of prolapsed outer jacket were also observed.Damage was seen to the distal tip.

Event Description

It was reported that during a vascular intervention procedure to treat a chronic total occlusion in peripheral vasculature, the guidewire became bent inside the turbo elite laser catheter, which in turn kinked the device.The device and wire were reportedly difficult to remove from the patient, but were removed successfully and without harm to the patient.Upon evaluation of the returned device, a breach to the outer jacket of the device was discovered.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

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; 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: 6565239
• MDR Text Key: 75318830
• Report Number: 1721279-2017-00085
• 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,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/25/2019
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ17A19A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Other