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

Model Number	G32224
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During insertion of the dilator through the valve at the proximal end of the sheath, the tip of the dilator became compressed, preventing it from being loaded onto the wire and thus deeming it unusable.Replacement used.

• Brand Name: FLEXOR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 24093612
• Report Number: 24093612
• Device Sequence Number: 10296035
• Product Code: DYB
• UDI-Device Identifier: 00827002322240
• UDI-Public: (01)00827002322240(17)280819(10)16747420
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/21/2025
• Report Date (Section F): 11/21/2025

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: G32224
• Device Catalogue Number: KCFW-6.0-38-40-RB-BLKN-HC
• Device Lot Number: 16747420
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/21/2025