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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT STENT GRAFT BALLOON CATHETER -OUS CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND RELIANT STENT GRAFT BALLOON CATHETER -OUS CATHETER, PERCUTANEOUS Back to Search Results
Model Number REL46J
Device Problems Leak/Splash (1354); Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

A reliant balloon was intended to be used in an unknown endovascular procedure. It was reported that when the device was being prepped, the saline solution could not pass through the guidewire lumen. It was thought there was some unevenness/roughness or foreign material in the lumen, thus the flushing could not be performed. As per the physician the cause of the event can not be determined. No additional clinical sequalae were provided and the patient is fine.

 
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Brand NameRELIANT STENT GRAFT BALLOON CATHETER -OUS
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 Key9961868
MDR Text Key187951425
Report Number9612164-2020-01568
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
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
Report Date 04/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREL46J
Device Catalogue NumberREL46J
Device LOT Number0010116403
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 Received04/10/2020
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 Initial

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