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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND RELIANT BALLOON CATHETER, PERCUTANEOUS Back to Search Results
Model Number AB46
Device Problems Burst Container or Vessel (1074); Device Damaged by Another Device (2915)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: ab46, serial/lot #:(b)(4), ubd: 10-feb-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Two reliant stent graft balloons were attempted to be used in the endovascular treatment of a 60 mm abdominal aortic aneurysm. It was reported that during the index procedure, two ab46 reliant stent graft balloon were attempted to be used to mount the proximal of the endurant stent graft, but the balloons burst once touched the endurant stent graft. It was stated that the procedure was completed using another ab46 reliant stent graft balloon no cause of the event was reported. No additional clinical sequalae were reported and the patient is fine.

 
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Brand NameRELIANT BALLOON
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
alison sweeney
parkmore business park west
galway 
091708096
MDR Report Key10634375
MDR Text Key219109553
Report Number9612164-2020-03779
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberK050038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberAB46
Device Catalogue NumberAB46
Device LOT Number0010214015
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/14/2020
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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