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

Model Number	G48189
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Adult male with history of non-healing wound, right foot.Procedure: right lower extremity angiogram.The tip of the flexor check-flo introducer was partially sealed, making the sheath unusable.Removed without known harm to patient, another device used without difficulty.Manufacturer response for introducer, catheter, flexor (per site reporter) will obtain.

• Brand Name: FLEXOR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 18542503
• Report Number: 18542503
• Device Sequence Number: 7779708
• Product Code: DYB
• UDI-Device Identifier: 00827002481893
• UDI-Public: (01)00827002481893(17)261011(10)15700243
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/04/2024
• Report Date (Section F): 01/04/2024

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: G48189
• Device Catalogue Number: KCFW-5.0-18/38-90-RB-ANL0-HC
• Device Lot Number: 15700243
• 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: 01/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 01/04/2024