MAUDE Adverse Event Report: COOK INC ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET; DYB; INTRODUCER, CATHETER

Model Number	G06929
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone number: (b)(6).H3: 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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported that the flexor sheath from a rosch-uchida transjugular liver access set was difficult to advance.During the unspecified procedure for a 69-year-old female patient, the operator suddenly noticed a significant increase in resistance while pushing the flexor sheath, and the sheath could not be smoothly advanced; this was accompanied by a slight and clear fracture like sound.Therefore, the operator immediately stopped advancing the sheath and gently and quickly removed the sheath completely from the surgical area.Subsequently, the surgeon conducted a preliminary visual inspection of the withdrawn sheath.No information regarding the state of the flexor sheath was provided at the time of initial report.The procedure was completed with a new device of the same catalog number.The subsequent procedure went smoothly with no abnormal situations occurring again.After the procedure, imaging was performed of the patient's surgical area to confirm no foreign matter residues; the patient's vital signs were stable.The returned device was returned and evaluated 05feb2026 revealing a broken flexor sheath, thus prompting this report.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

• Brand Name: ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET
• 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: 24370824
• Report Number: 1820334-2026-00180
• Device Sequence Number: 14655354
• Product Code: DYB
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K171820
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: G06929
• Device Catalogue Number: RUPS-100
• Device Lot Number: 16515016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 65 KG