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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 Insufficient Information (3190)
Patient Problem Vascular Dissection (3160)
Event Date 08/04/2021
Event Type  Injury  
Manufacturer Narrative

A review of the manufacturing records for the device is going to be conducted. The investigation is in process. Further information will be provided. The balloon was discarded at the facility and is not available for investigation.

 
Event Description

The following was reported to gore: on (b)(6) 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis, a gore® excluder® iliac branch endoprosthesis, gore® dryseal flex introducer sheaths and a gore® molding & occlusion balloon catheter. After all devices were implanted, final angiography suspected a dissection at about 3cm below from the proximal end of the trunk ipsilateral leg component. An aortic extender endoprosthesis was implanted. Then, the angiography still suspected the dissection, but no additional treatment was performed. The procedure was concluded. The physician stated that it was unknown when the dissection occurred. Reportedly, it was unknow if there was something in patient¿s anatomy caused or contributed to the event. The fsa reported also that two 16fr sheaths and a balloon which were used during the procedure might have been related to the dissection. Reportedly, there was no other reportable issue during the procedure. The patient tolerated the procedure. No reintervention was performed. The physician is monitoring the patient.

 
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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
nataliya baramzina
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12310758
MDR Text Key266164307
Report Number3007284313-2021-01544
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 COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2021
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 Received08/17/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/02/2020
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: 08/11/2021 Patient Sequence Number: 1
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