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	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- phone number: (b)(6).H3 - device evaluated by mfg: the 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.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 included in the rosch-uchida transjugular liver access set broke at the shaft during a transjugular intrahepatic portosystemic shunt (tips) procedure for a 53-year-old male patient.The patient was admitted to the hospital on (b)(6) 2025 with a history of liver cirrhosis and esophageal varices.On (b)(6) 2024, after inserting the device percutaneously, the hemostatic valve separated from the introducer sheath.Upon noting this separation, the product was immediately replaced with a new device to continue the procedure.The only component advanced through the sheath when it broke was the stylet.Customer provided photo reveals sheath shaft separated near the flare of the check flo valve.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Additional information: d9: date returned to manufacturer.Correction: d10.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 or that a death or serious injury occurred; nor is it admission 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
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation it was reported that the flexor sheath included in the rosch-uchida transjugular liver access set broke at the shaft during a transjugular intrahepatic portosystemic shunt (tips) procedure.The customer stated that after the puncture site was selected during the procedure, the puncture was performed, and the sheath hub had separated from the shaft of the sheath.A replacement device was used to complete the procedure.No adverse effects were reported.Reviews of the documentation including the complaint history, device history record, quality control procedures and instructions for use (ifu), as well as a visual inspection of the returned device, were completed during the investigation.One used set was received for evaluation.The sheath shaft was separated from the hub, resulting in the inner coil being exposed.Sheath material was found in the hub.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) found no relevant nonconformances that could have contributed to the reported failure.It should be noted that there were no other complaints associated with the final product lot number.Cook was unable to review product labeling, as this product is not supplied with an instructions for use (ifu) pamphlet.Instructions for use are applied by the local distribution partner.Evidence provided by a review of the dmr, dhr and returned product, there is no indication the complaint device was manufactured out of specification.Cook did not identify any nonconforming material in house or in the field.Based on the information provided, examination of the returned device, and the results of this investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported incident.It is possible that as the metal stiffening cannula was being advanced through the sheath, resistance was encountered due to possible patient anatomy.This could have contributed to the separation.However, this cannot be confirmed without additional information.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• 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: 21977634
• Report Number: 1820334-2025-00487
• Device Sequence Number: 9188744
• Product Code: DYB
• UDI-Device Identifier: 00827002069299
• UDI-Public: (01)00827002069299(17)270826(10)16223654
• 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,Followup
• Report Date (Section B): 11/20/2025

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: 16223654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: Not provided; 11/07/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/03/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: TERUMO WIRE GUIDE
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian