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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6227DEF02
Device Problem Use of Device Problem (1670)
Patient Problem Complete Heart Block (2627)
Event Date 11/02/2017
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that during use of the delivery catheter, the atrial-ventricular (av) node was touched by the delivery catheter, and suppression of the av node with mechanical or electro-physiological impact disabled the av node conduction capability which induced av block. Status of the delivery catheter is unknown. No further patient complications have been reported as a result of this event.

 
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Brand NameATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM
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 Key7254643
MDR Text Key99583956
Report Number9612164-2018-00250
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK061480
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 02/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6227DEF02
Device Catalogue Number6227DEF02
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/08/2018 Patient Sequence Number: 1
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