MAUDE Adverse Event Report: COOK INCORPORATED FLEXOR TUOHY-BORST SIDE-ARM INTRODUCER SHUTTLE SHEATH; INTRODUCER, CATHETER

Model Number	G13264
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was undergoing a carotid stent placement.The physician was removing a shuttle sheath from his left femoral artery and it tore apart leaving a portion of the sheath in the patients artery.Fda safety report id# (b)(4).

• Brand Name: FLEXOR TUOHY-BORST SIDE-ARM INTRODUCER SHUTTLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED ; bloomington IN 47404
• MDR Report Key: 11514944
• Report Number: MW5100083
• Device Sequence Number: 2966075
• Product Code: DYB
• UDI-Device Identifier: 00827002132641
• UDI-Public: (01)00827002132641(17)240127(10)
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: G13264
• Device Catalogue Number: KSAW-6.O-38-90-RB-SHTL-HC
• Device Lot Number: 13719660
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82