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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 Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/22/2020
Event Type  malfunction  
Event Description
From staff: there was an aortic balloon placed on the surgical field. It was introduced into the patient via the femoral artery in an introducer sheath. When the surgeon went to inflate with the contrast syringe attached it was felt that it took an unreasonable amount of pressure to get the balloon to inflate. The balloon was then taken out of the patient and passed off the field. There was no harm done to the patient and we had a substitute balloon of a different company available to use. Manufacturer response for catheter, intravascular occluding, temporary, gore molding occlusion balloon catheter (per site reporter). Rep was aware. Do not have reps name.
 
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Brand NameGORE MOLDING OCCLUSION BALLOON CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
W. L. GORE ASSOCIATES, INC.
1505 north fourth st.
flagstaff AZ 86004
MDR Report Key10361549
MDR Text Key201524723
Report Number10361549
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMOB37
Device Catalogue NumberMOB37
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2020
Event Location Hospital
Date Report to Manufacturer08/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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