MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT CATHETER, PERCUTANEOUS

Model Number C315S1002

Device Problem Device Damaged by Another Device (2915)

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

Event Date 12/04/2017

Event Type  Malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the catheter was more difficult to cut that expected and the slitter slipped off the guide. The lead was caught in the rift that was formed by slitting which damaged the insulation on the lead. The lead was not used, and another lead was implanted. No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the delivery catheter was returned and analyzed. The mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit. Visual analysis of the lead indicated damage during use. If information is provided in the future, a supplemental report will be issued.

• Brand Name: DEFLECT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7255080
• MDR Text Key: 99919782
• Report Number: 9612164-2018-00260
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K101885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/08/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 01/16/2019
• Device MODEL Number: C315S1002
• Device Catalogue Number: C315S1002
• Device LOT Number: 0008450452
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial