MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB); CATHETER, PERCUTANEOUS

Catalog Number MOB37

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Perforation of Vessels (2135)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

Since it is unknown which of the reported balloon catheters was alleged against the event, device udi for both devices will be listed below.Lot/serial: (b)(4), udi: (b)(4).Lot/serial: (b)(4), udi: (b)(4).

Event Description

On (b)(6) 2018, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.A trunk-ipsilateral leg component was deployed from the right side, followed by two contralateral leg components implanted.When touch-up ballooning was performed for the contralateral leg component on the right side using a gore® molding and occlusion balloon (mob) catheter (either mob37/18151600 or mob37/18156237), the patient¿s right common iliac artery was ruptured.It was reported that the patient¿s common iliac arteries were calcified, which could have contributed to the vessel rupture.The right internal iliac artery was coi-embolized and another contralateral leg component was implanted to repair the rupture.The patient tolerated the procedure without further problems.

• Brand Name: AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8049320
• MDR Text Key: 126509423
• Report Number: 3007284313-2018-00308
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2020
• Device Catalogue Number: MOB37
• Device Lot Number: 18151600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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: 71 YR