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 Rupture (2208)

Event Date 12/10/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment using gore® molding & occlusion balloon (mob) and gore® excluder® aaa endoprosthesis for abdominal aortic aneurysm.Reportedly, the patient had strong calcification and small vessel diameter due to dialysis.After deployment the stent grafts, ballooning was performed to reinforce the sealing on the proximal side.It was reported that the balloon was inside the stent graft during ballooning.Angiography showed rupture near the proximal end of the stent graft.Additional stent grafts were deployed to extend the device proximally.Vitals were stable, but angiography confirmed leakage.The procedure was converted to open repair.The patient tolerated the procedure.The physician stated that the balloon was over-inflated.

Manufacturer Narrative

H6: code 213.H6: code 18 - as reported, the physician over-inflated the molding and occlusion balloon catheter.

• 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: 13096668
• MDR Text Key: 282845850
• Report Number: 3007284313-2021-01726
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2023
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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: 81 YR
• Patient Sex: Female