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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS

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W.L. GORE & ASSOCIATES AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number MOB37
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aneurysm (1708)
Event Date 07/30/2019
Event Type  Injury  
Manufacturer Narrative
The udi for the mob37 balloon is not available since the device lot number is unavailable. A review of the manufacturing records for the device was not possible since the device lot number is unavailable. Per the gore® molding and occlusion balloon catheter instructions for use, adverse events which may require intervention include, but are not limited to: trauma to the vessel wall, including dissection.
 
Event Description
On (b)(6) 2019, this patient underwent an endovascular repair for an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis. The endoprosthesis was deployed, and touch-up ballooning was performed using a gore® molding and occlusion balloon catheter. Post implant and ballooning, a localized dissection at the distal edge of the contralateral leg component in the right common iliac artery was observed, and the physician elected to monitor it. No further issue reported, and the procedure was completed. The patient tolerated the procedure.
 
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Brand NameAORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL PHOENIX 1 B/P
32360 n. north valley parkway
phoenix AZ 85085
Manufacturer Contact
rachael chascsa
1500 n. 4th street
9285263030
MDR Report Key8930840
MDR Text Key155517848
Report Number3007284313-2019-00261
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMOB37
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/26/2019 Patient Sequence Number: 1
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