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

Model Number 410-152

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.Visual investigation of the device found heavy damage to the device tip.The epoxy cap had been heavily damaged.A combination of patient tissue and epoxy was present at the tip of the device.The distal marker band was found to be present and attached, although it was buried within the material at the tip of the device.This damage is attributed to the overuse of the device.

Event Description

It was reported that during a peripheral vascular intervention procedure, the tip of the turbo elite device became loose.Reportedly, the physician was lasing an isr lesion within a viabahn stent.The first pass was completed at a fluence/pulse setting of 45/45, then was increased to 80/80 for the second pass.During the second pass, it was identified that the distal marker band was becoming or had become disconnected.The pass was completed and the device was removed with the marker band still attached.The case was then completed with pta and dcb.The patient was not affected.

• 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: 6916989
• MDR Text Key: 90029917
• Report Number: 1721279-2017-00216
• 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: 09/08/2017

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: 08/09/2019
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD17H04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• 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
• Patient Age: 80 YR
• Patient Weight: 99