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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 Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Tingling (2171); Rupture (2208); Reaction (2414)
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 25 years, who has used the reliant device for expansion of vascular prostheses 200 times in total of which 35 of those times were in the last 12 months. For the temporary occlusion of large vessels the physician has used it 75 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 following complications were encountered; allergic response to materials (very strong sensitivity from the start of the first procedure, sometimes requiring adrenaline to administer), hematoma (it always occurs, but to varying degrees, and is difficult to control), vessel perforation or dissection, paresthesia (it continues after the procedure for several days and returns spontaneously), entry site infection (it happened several times, and in one of them the patient was to go into toxic shock, it was reported that antibiotic coverage should be considered before the procedure), entry site hematoma, stent graft migration caused by balloon catheter device, inability to insert guidewire, (because of the sometimes formed hematoma), balloon rupture (it occurred several times spontaneously and inexplicably). The physician found the allergic response to materials, haemtoma and vessel perforation or dissection events very concerning, somewhat concerning and not at all concerning. The parathesia events somewhat concerning and not at all concerning, the entry site infection very concerning and somewhat concerning, the entry site haematoma events very concerning, not at all concerning and somewhat concerning. The stent graft migration, inability to insert guidewire and the balloon rupture were found to be somewhat concerning and not at all concerning, all of the events were reported to be related to the device on at least one occasion. During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; vessel perforation or dissection (it happened two or three times, but can be easily bypassed), entry site hematoma (it usually occurs, but to varying degrees ), aneurysm rupture ( torn when starting to enter on two occasions unexplained and irreversible), hemorrhage (in several cases) , inability to inflate/deflate balloon (it almost caused a fatal problem for the patient), balloon rupture (the rupture is at the beginning of the procedure). The physician found the vessel perforation or dissection, entry site hematoma, aneurysm rupture and hemorrhage events very concerning, somewhat concerning and not at all concerning. The inability to inflate/deflate balloon very concerning and somewhat concerning. The balloon rupture somewhat concerning, very concerning and not at all concerning. All of the events were reported to be related to the device on at least one occasion each. 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 Key10025594
MDR Text Key196943765
Report Number9612164-2020-01776
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
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 Received05/05/2020
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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