MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 423-135-02

Device Problems Break (1069); Melted (1385); Particulates (1451); Device Displays Incorrect Message (2591)

Patient Problem Stenosis (2263)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

Patient date of birth and age unavailable.Patient weight unavailable.

Event Description

In an in-stent restenosis procedure involving the femoral artery, a 2.3 turbo elite device was in use when, after 2 passes, the team smelled melted plastic and the laser system indicated an error.The guide wire in the procedure was damaged, and when the turbo elite device was removed, it was observed that it was damaged at the tip, with reported hydrophilic particles present.A new device was then used with a different type of guide wire, and the procedure was completed successfully with no reported patient harm.

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6930895
• MDR Text Key: 88924257
• Report Number: 1721279-2017-00223
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123632
• 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: 09/13/2017

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: 10/04/2018
• Device Model Number: 423-135-02
• Device Catalogue Number: 423-135-02
• Device Lot Number: FBN16L04A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2016
• 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): Required Intervention