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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Perforation (2001); Vascular Dissection (3160); Embolism/Embolus (4438)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the reliant device. The exact size of the device is unknown. Survey results from a medical equipment maker in practice 10 years, who has used the reliant device for expansion of vascular prostheses 50 times in total of which 25 of those times were in the last 12 months. For the temporary occlusion of large vessels the device was used 50 times in total of which 25 of those times were in the last 12 months. During use of the reliant for expansion of vascular prostheses (assisting in the expansion of self-expanding stent grafts), the fol lowing complications were encountered; emboli (not related to device itself) , balloon rupture (not related to device itself) , vessel perforation or dissection (not related to device itself) during use of the reliant for temporary occlusion of large vessels, the following complications were encountered; stroke (not related to device itself) , balloon rupture (not related to device itself) of the above complications reported, some of these are listed as having been reported to medtronic previously. Due to limited information these are included in reporting. No further information has or will be provided.

 
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Brand NameRELIANT BALLOON
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key12317581
MDR Text Key266359642
Report Number9612164-2021-03124
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
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 08/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberAB46
Device Catalogue NumberAB46
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 Received07/02/2021
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

Patient TREATMENT DATA
Date Received: 08/13/2021 Patient Sequence Number: 1
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