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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN COMMAND CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND ATTAIN COMMAND CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6250VIS
Device Problems Split (2537); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that during the implant procedure, the left ventricular (lv) lead could not be fixed in the target vein and it "fell off by several attempts," or dislodged several times. When withdrawing the delivery catheter, the catheter could not be cut normally and split at the hemostatic valve, which resulted in failure of the removal of the catheter and the lead. The catheters and lead were not implanted. No patient complications have been reported as a result of this event.

 
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Brand NameATTAIN COMMAND
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 Key7413773
MDR Text Key105269128
Report Number9612164-2018-00683
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK123153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/07/2018
Device MODEL Number6250VIS
Device Catalogue Number6250VIS
Device LOT Number0008668361
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/08/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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