• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)
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 15 years, who has used the reliant device for expansion of vascular prostheses 12 times over the last 12 months and used it 8 times in total in the last 12 months for the temporary occlusion of large vessels. 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; blood loss/bleeding (above-normal hb -relevant bleeding), hematoma (above-normal haematoma formation), embolization (micro or macro) with transient or permanent ischemia (ischaemic stroke), vessel perforation or dissection (vascular trauma requiring further surgery) , general malaise, entry site hematoma (above-average haematoma on the puncture), entry site infection (infection requiring antibiotics), hemorrhage (drop in thrombocytes blood loss) , renal complications (acute kidney failure until dialysis). The physician found the blood loss events somewhat concerning and not at all concerning, the hematoma events were not at all concerning, the embolization events very concerning, the vessel perforation or dissection events somewhat concerning, the general malaise events not at all concerning, the entry site infection events not at all concerning, the entry site haematoma events not at all concerning, the hemorrhage events somewhat concerning and not at all concerning, and the renal complications not at all concerning and somewhat concerning. Of the these adverse events were reported to be related to the device itself. During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; vessel perforation or dissection (dissection of the vessel with another operation needed), general malaise [az] reduction) , entry site hematoma (formation of a significant haematoma), stroke (ischaemic stroke) and renal complications (acute renal failure). The physician found the vessel perforation or dissection events very concerning, the general malaise events somewhat concerning and not at all concerning, the entry site haematoma events not at all concerning, the stroke events somewhat concerning, the renal complications somewhat concerning and not at all concerning. None of these complications were deemed to be related to the 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10005384
MDR Text Key194536609
Report Number9612164-2020-01702
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGM
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
Report Date 06/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2020
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 Received06/05/2020
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

Patient TREATMENT DATA
Date Received: 04/28/2020 Patient Sequence Number: 1
-
-