MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G29989
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluation anticipated but not yet begun.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
As reported, during a procedure involving intervention of the right leg via contralateral access in the left groin, the hub of a flexor ansel guiding sheath separated.Per the reporter, as the sheath was removed from the left groin, over a wire guide and ¿up and over¿, the check-flo valve came off.The dilator and guidewire were in the lumen of the sheath when the separation occurred.The sheath hub was used to pull the device from the patient.The access site was "normal", the anatomy was not stenosed, calcified, or tortuous.The bifurcation was acute.Resistance was not encountered during insertion or advancement of the sheath or during insertion or advancement of any device through the sheath.Resistance was encountered during removal of the sheath.Another manufacturer's laser and balloon were used through the sheath during the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 25722288
• Report Number: 1820334-2026-00714
• Device Sequence Number: 18501567
• Product Code: DYB
• UDI-Device Identifier: 00827002299894
• UDI-Public: (01)00827002299894(17)290428(10)17106485
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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: G29989
• Device Catalogue Number: KCFW-6.0-18/38-90-RB-ANL1-HC
• Device Lot Number: 17106485
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 260CM UNIGLIDE WIRE; ABBOTT PTA BALLOON; AURYON ATHERECTOMY LASER
• Patient Sex: Unknown