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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 Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation (2001)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 an interventional cardiologist in practice 8 years, who has used the reliant device for expansion of vascular prostheses 400 times in total of which 200 of those times were in the last 12 months. For the temporary occlusion of large vessels it was used 800 times in total of which 400 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 following complications were encountered: entry site hematoma, hemorrhage, inability to inflate/deflate balloon. The physician found the entry site haemotoma events very concerning, somewhat concerning and not all concerning. The hemorrhage events very concerning, somewhat concerning and not at all concerning. The inability to inflate/deflate balloon very concerning, somewhat concerning and not all concerning. All of the events were reported to be related to the device on at least one occasion each. During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; vessel perforation or dissection. The physician found these events very concerning, somewhat concerning and not all concerning. These events were deemed to be related to the device on at least one occasion. 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
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
091708096
MDR Report Key10013151
MDR Text Key194471718
Report Number9612164-2020-01730
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K050038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/08/2020
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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