MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE DRYSEAL SHEATH WITH HYDROPHILIC COATING; INTRODUCER, CATHETER

Device Problems Material Puncture/Hole (1504); Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

The patient was treated for an abdominal aortic aneurysm.Before inserting the gore® excluder® aaa endoprosthesis featuring c3® delivery system into the gore® dryseal sheath with hydrophilic coating, it was noted that a wire was protruding from the delivery system just below the olive.It was reported to be a gold-silver color.The device was inserted into the sheath, and the sheath balloon valve was punctured.The device and sheath were removed and discarded, and a new sheath and delivery system were used.The procedure was successfully completed, and the patient tolerated the procedure.The fsa stated that the observed wire was definitely not the lock pin, nor was it part of the structure of the device.He believes that it was the constraining wire loop.

Manufacturer Narrative

Medwatch #3007284313-2020-01135 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch will be retracted.

• Brand Name: GORE DRYSEAL SHEATH WITH HYDROPHILIC COATING
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10748696
• MDR Text Key: 213478503
• Report Number: 3007284313-2020-01135
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR