MAUDE Adverse Event Report: W.L. GORE AND ASSOCIATES, INC. GORE; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 17229409A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/08/2018

Event Type  malfunction  

Event Description

The "nose cone" (tip) broke off the instrument inside of the patient.

• Brand Name: GORE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE AND ASSOCIATES, INC. ; flagstaff AZ 86004
• MDR Report Key: 7506279
• MDR Text Key: 108136112
• Report Number: MW5077140
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132617722
• UDI-Public: (01)00733132617722
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Model Number: 17229409A
• Device Catalogue Number: TGU373710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 89 YR