MAUDE Adverse Event Report: Cook Inc FLEXOR BALKIN GUIDING SHEATH; DYB Introducer, Catheter

Model Number	G10384
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	09/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, upon insertion of the device during an unknown procedure, a flexor balkin guiding sheath leaked fluid from the valve.A photo provided by the customer shows separation of the hub and separation of the side-arm tubing.Contralateral access was obtained in the femoral artery.The access site was not scarred or calcified, and the anatomy was not stenosed, calcified, or tortuous.The bifurcation was not steep or calcified.No other devices were used through the sheath during the procedure.Resistance was not encountered during insertion/advancement or removal of the sheath.The leak, hub separation, and side-arm separation occurred during the ¿insertion stage¿.The device was not pulled by the side-arm during the procedure.Another device of the same type, from a different lot, was used to successfully complete the procedure.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: (b)(6) h3: the device has been returned, and preliminary evaluation has been performed; however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.

• 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 ; +1(812)339-2235
• MDR Report Key: 50947305
• Report Number: 1820334-2026-01023
• Device Sequence Number: 10451637
• Product Code: DYB
• UDI-Device Identifier: 00827002103849
• UDI-Public: (01)00827002103849(17)290407(10)17074624
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: G10384
• Device Catalogue Number: KCFW-7.0-38-40-RB-BLKN
• Device Lot Number: 17074624
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2026
• 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
• Patient Sex: Unknown