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

Catalog Number MOB37

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

The udi for the mob37 balloon is not available since the device lot number is unavailable.A review of the manufacturing records for the device was not possible since the device lot number is unavailable.Per the gore® molding and occlusion balloon catheter instructions for use, adverse events which may require intervention include, but are not limited to: trauma to the vessel wall, including dissection.

Event Description

On (b)(6) 2019, this patient underwent an endovascular repair for an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.The endoprosthesis was deployed, and touch-up ballooning was performed using a gore® molding and occlusion balloon catheter.Post implant and ballooning, a localized dissection at the distal edge of the contralateral leg component in the right common iliac artery was observed, and the physician elected to monitor it.No further issue reported, and the procedure was completed.The patient tolerated the procedure.

Manufacturer Narrative

Addition g5: 510(k) number: k172567.

Manufacturer Narrative

Correction b5.

Event Description

On (b)(6), 2019, this patient underwent an endovascular repair for an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.

• Brand Name: AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8930840
• MDR Text Key: 155517848
• Report Number: 3007284313-2019-00261
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR