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

Model Number DSF1065

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/17/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, during a reintervention procedure on a previously implanted cook zenith device, a gore® dryseal 10fr sheath was used during an "up and over" procedure to implant a gore® excluder® iliac branch endoprosthesis device.After the device were implanted, resistance was felt during retraction of the gore® dryseal 10fr sheath.Much force was exerted to try to withdraw the sheath.Finally, the sheath withdrew, however, the leading olive became dislodged from the sheath and remained inside the patient.The physician retrieved the olive using a snare.There was no adverse outcome to the patient.Excessive tortuosity was also reported, but the physician does not believe tortuosity was an issue with retraction of the sheath.

Manufacturer Narrative

H10/11: engineering evaluation summary - the device evaluation found the sheath coil had been pulled out of the leading end of the device and was wrapped around a guidewire that was inside the sheath.Multiple pieces of the sheath were found along the length of the guidewire.A marker band was not present.The root cause of the sheath damage could not be determined with the available information.

• Brand Name: GORE DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11164628
• MDR Text Key: 249997078
• Report Number: 2017233-2021-01599
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132628261
• UDI-Public: 00733132628261
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Model Number: DSF1065
• Device Catalogue Number: DSF1065
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 12/17/2020; 12/17/2020
• Supplement Dates FDA Received: 03/10/2021; 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 88