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

Model Number	G30009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: occupation = css logistics specialist h3: device evaluation has begun; however, a conclusion is not yet available.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 balloon angioplasty of the tibial artery, a flexor shuttle tibial guiding sheath separated at the hub upon removal of the device from the patient.The patient was heparinized and contralateral access was obtained in the left groin.The anatomy, including the access site and the aortic bifurcation, was calcified.Minimal resistance was encountered upon insertion/advancement of the sheath and during insertion/advancement of other devices through the sheath.Per the reporter, half-way through the case, while attempting to retract the sheath a ¿short distance¿ by pulling the sheath by the hub, significant resistance was encountered, and the sheath broke.The dilator was not reinserted prior to removal.Another manufacturer¿s 5-millimeter balloon catheter was in the sheath lumen at the time of the event.The complaint device was exchanged for a 5-french cook flexor ansel sheath.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.Upon return and initial evaluation of the device, the sheath was separated just below the hub.

• Brand Name: FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 24705748
• Report Number: 1820334-2026-00331
• Device Sequence Number: 10557377
• Product Code: DYB
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: G30009
• Device Catalogue Number: KSAW-5.0-18/38-90-RB-SHTL-HC
• Device Lot Number: 16459387
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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: 5MM MUSTANG BALLOON CATHETER
• Patient Age: 88 YR
• Patient Sex: Unknown
• Patient Weight: 83 LB