MAUDE Adverse Event Report: COOK INCORPORATED FLEXOR; INTRODUCER, CATHETER

Model Number	G30009
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of the procedure.The 5fr 90cm shuttle sheath was exchange for a shorter sheath.During the exchange the shuttle sheath elongated and broke into three pieces.The sheath was able to be retrieve and remove.Post angiogram showed no dissection or extravasation.

• Brand Name: FLEXOR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 18563089
• Report Number: 18563089
• Device Sequence Number: 8034037
• Product Code: DYB
• UDI-Device Identifier: 00827002300095
• UDI-Public: (01)00827002300095
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/02/2023
• Report Date (Section F): 10/02/2023

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 Model Number: G30009
• Device Catalogue Number: KSAW-5.0-18/38-90-RB-SHTL-HC
• Device Lot Number: 14777389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 10/02/2023