MAUDE Adverse Event Report: GORE MEDICAL GORE DRYSEAL SHEATH; INTRODUCER, CATHETER

Device Problems Malposition of Device (2616); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic aortic valve, a kink in the gore dry seal sheath caused resistance when advancing the delivery catheter system (dcs).Once the dcs was removed from the sheath, the capsule had been pushed over the nose-cone.A different dcs was used for a successful implant.No adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: GORE DRYSEAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GORE MEDICAL
• MDR Report Key: 17536440
• MDR Text Key: 321473559
• Report Number: MW5143328
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1