MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® MOLDING & OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS

Model Number MOB37

Device Problem Device Handling Problem (3265)

Patient Problem Pseudoaneurysm (2605)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2022, this patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.After all devices were implanted, a distal type i endoleak in the right leg was identified.An additional contralateral leg endoprosthesis (plc231000j/(b)(4)) was implanted in the right leg.The distal type i endoleak was resolved.The patient tolerated the procedure.On (b)(6) 2022, a follow-up cta revealed a pseudoaneurysm in the distal portion of the right common iliac artery.On (b)(6) 2022, the right internal iliac artery was coil embolized and a contralateral leg endoprosthesis was implanted to extend the right leg to the external iliac artery.The physician stated that the pseudoaneurysm might have been caused by excessive ballooning using gore® molding & occlusion balloon catheter in the contralateral leg endoprosthesis in the initial procedure to attempt to resolve the distal type i endoleak.

• Brand Name: GORE® MOLDING & OCCLUSION BALLOON CATHETER
• Type of Device: 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: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13656031
• MDR Text Key: 290535172
• Report Number: 3007284313-2022-01800
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2023
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male