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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND DEFLECT CATHETER, PERCUTANEOUS Back to Search Results
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.

 
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Brand NameDEFLECT
Type of DeviceCATHETER, 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 Key7255080
MDR Text Key99919782
Report Number9612164-2018-00260
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK101885
Number of Events Reported1
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 Received02/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/16/2019
Device MODEL NumberC315S1002
Device Catalogue NumberC315S1002
Device LOT Number0008450452
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/13/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/16/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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