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

Model Number	BCM1634
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): on an unknown date, the patient was implanted with several gore® excluder® aftermarket devices, as well as the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).During the procedure three dryseal flex introducer sheath were used, as well as a gore® mob balloon, a gore® tri-lobe balloon and a gore® tri lumen catheter.Gore was unable to determine which of the implanted devices or gore accessories were involved in the event.It was reported that on (b)(6) 2022, the patient presented with femoral compartment syndrome (unknown if it was on the left or right side).The physician reintervened and performed a fasciotomy.The patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
Additional investigation determined no product problem or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch was submitted in error, and is hereby retracted.

• Brand Name: GORE® TRI-LOBE BALLOON CATHETER
• Common Device Name: CATHETER, 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14597155
• Report Number: 3007284313-2022-01949
• Device Sequence Number: 12119198
• Product Code: DQY
• UDI-Device Identifier: 00733132605231
• UDI-Public: 00733132605231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2024
• Device Model Number: BCM1634
• Device Catalogue Number: BCM1634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male