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

Catalog Number	MOB37
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: d1102, ifu statements: the gore® molding & occlusion balloon catheter instructions for use (ifu) was reviewed and the following ifu statements were identified in relation to the reported event.See recommended inflation volumes outlined in table 1.Do not inflate above recommended inflation volumes.Excessive inflation volume may result in balloon rupture, embolization, vessel damage, vessel rupture, or patient death.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2026, the patient underwent endovascular treatment for an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis and gore® excluder®aaa endoprosthesis devices.Following deployment of these devices, a balloon touch-up was performed using a gore® mob balloon catheter.Subsequent angiography confirmed a distal type i endoleak originating from the right distal side.After additional balloon touch-up was performed at the site using the mob balloon, a vessel injury resembling a dissection occurred in the right common iliac artery.As a treatment, coil embolization of the right internal iliac artery was performed, followed by placement of an additional stent graft extending to the right external iliac artery to resolve the endoleak.The patient tolerated the procedure.The physician reported that excessive balloon pressure had been applied during the balloon touch-up.The anatomical configuration made it challenging to achieve a secure distal landing zone in the right common iliac artery.Therefore, aggressive ballooning in response to the distal type i endoleak should have been avoided.

• Brand Name: GORE® MOLDING & OCCLUSION BALLOON CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: rie kaba ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24492828
• Report Number: 3007284313-2026-04607
• Device Sequence Number: 4955291
• Product Code: MJN
• UDI-Device Identifier: 00733132639489
• UDI-Public: (01)00733132639489(17)280922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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 Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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: 81 YR
• Patient Sex: Male