MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 420-159

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.This notification is marked due to a field safety notice which was issued, containing safety concerns regarding off label use of this model of device being used within a stent.

Event Description

In an in-stent restenosis procedure, a turbo elite rapid exchange device was being used off-label.During the procedure, the distal marker tip came detached from the catheter.It was retrieved from out of the patient, and the case was successfully completed 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: 7149441
• MDR Text Key: 95896911
• Report Number: 1721279-2017-00301
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/05/2017

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: 10/23/2019
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH17K17A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• 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): Required Intervention