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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS

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W. L. GORE & ASSOCIATES, INC. GORE TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number BCL2645J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 07/14/2021
Event Type  Injury  
Manufacturer Narrative

Medical device was discarded at facility. Return not possible. (b)(4). Use of an additional or alternative device was required to achieve optimal outcome. Additional stent grafts were implanted. An adverse event (e. G. Patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used. The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event. The investigation involved communication/interviews (either interpersonal or through technical means, e. G. Phone, e-mail) with persons close to the adverse event, e. G. Healthcare professionals (doctors, nurses etc. ), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient. The actual device involved in the adverse event was not returned for testing despite requests by manufacturer. Medical device was discarded at facility. Investigation is ongoing, and results are not yet available. (do not use this code if the investigation is complete). The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

 
Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment of a traumatic aortic injury with type b aortic dissection using gore® tag® conformable thoracic stent graft with active control system. After implantation of ctagac, balloon touch-up was performed by using gore® tri-lobe balloon catheter to treat an endoleak and the procedure was completed. On (b)(6) 2021, the patient was transported to emergency due to chest pain. Stent graft induced new entry (sine) was detected in both proximal and distal sides. On (b)(6) 2021, a reintervention took place whereby additional stent grafts were implanted, proximally and distally. Reportedly it was most likely a case of traumatic aortic injury with type b aortic dissection based on ct data review.

 
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Brand NameGORE TRI-LOBE 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
samir kulovic
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12342724
MDR Text Key267279529
Report Number3007284313-2021-01552
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberBCL2645
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 09/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberBCL2645J
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 Received07/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/29/2020
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: 08/19/2021 Patient Sequence Number: 1
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