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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER CATHETER, PERCUTANEOUS

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W. L. GORE & ASSOCIATES, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number MOB37
Device Problem Use of Incorrect Control Settings (1126)
Patient Problem Aneurysm (1708)
Event Date 11/19/2020
Event Type  Injury  
Manufacturer Narrative

The instructions for use (ifu) for the the gore® molding and occlusion balloon catheter states, adverse events which may require intervention include, but are not limited to: trauma to the vessel wall, including spasm, dissection, perforation or rupture. A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

 
Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses. Post deployment antgioplasty with a gore® molding & occlusion balloon (mob) was performed. Post angioplasty angiography revealed the a localized dissection at the distal end of the left limb of the trunk ipsilateral leg component. A bare metal stent was deployed to extend the device distally and treat the dissection. It was reported that the balloon touch-up using mob might have been slightly over-inflated.

 
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Brand NameGORE MOLDING & OCCLUSION BALLOON CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MEDICAL PHOENIX 1 B/P
32360 n. north valley parkway
phoenix AZ 85085
Manufacturer Contact
laura crawford
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11006522
MDR Text Key221534736
Report Number3007284313-2020-01196
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK172567
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMOB37
Device Catalogue NumberMOB37
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 Received11/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/08/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/15/2020 Patient Sequence Number: 1
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