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

Model Number	G10383
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	05/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an angiogram of the leg via contralateral access in the right common femoral artery, the hub of a flexor balkin guiding sheath separated during removal of the device.The access site was scarred, and the aortic bifurcation was tight and steep/acute.Per the reporter, resistance was encountered and the sheath was difficult to advance up-and-over the aortic bifurcation.Resistance was not encountered upon insertion or advancement of other manufacturers¿ balloons and stent through the sheath.The hub did not leak.The dilator was not reinserted prior to sheath removal.Upon removal of the sheath, resistance was encountered, and the hub separated.It is unknown if the hub was used to pull the device from the patient.Resistance was also encountered as the shaft of the sheath was removed with a clamp, after the hub separated.The patient did not require treatment for blood loss.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 BALKIN 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: 25594945
• Report Number: 1820334-2026-00659
• Device Sequence Number: 5382104
• Product Code: DYB
• UDI-Device Identifier: 00827002103832
• UDI-Public: (01)00827002103832(17)290108(10)16935729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: G10383
• Device Catalogue Number: KCFW-6.0-38-40-RB-BLKN
• Device Lot Number: 16935729
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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: ELUVIA STENT.; RANGER DCB.; SHOCKWAVE BALLOONS.
• Patient Age: 80 YR
• Patient Sex: Unknown