MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TRI-LOBE BALLOON CATHETER (MODIFIED); CATHETER, PERCUTANEOUS

Catalog Number	BCL2645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: alprazolam, simvastatin, advair, metoprolol tartrate, and hydrochlorothiazide.
Event or Problem Description
On (b)(6) 2019, the patient was implanted with conformable gore® tag® thoracic stent graft with active control systems (tgmr373715/20930111) while utilizing a gore® tri-lobe balloon catheter (bcl2645/18292403).It was reported the patients descending thoracic aorta ruptured when ballooned at the distal device.We extended the ruptured area with another 37x15 device.All subsequent aorta grams showed no leak, however, patient¿s pressure is still being actively managed.The patient tolerated the procedure.

• Brand Name: AORTIC TRI-LOBE BALLOON CATHETER (MODIFIED)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9331903
• Report Number: 3007284313-2019-00348
• Device Sequence Number: 1927701
• Product Code: DQY
• UDI-Device Identifier: 00733132605224
• UDI-Public: 00733132605224
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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: 06/25/2021
• Device Catalogue Number: BCL2645
• Device Lot Number: 18292403
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Weight: 65