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

Model Number	G06929
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - customer (person): phone: (b)(6).H3 - device evaluated by mfg.Device has been returned, and preliminary evaluation has been performed.However, the investigation is ongoing.The device evaluation summary will be included in the follow up report once the 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 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
It was reported that the hub separated from the introducer catheter in a rosch-uchida transjugular liver access set.The transjugular liver access set was required for a patient undergoing a transjugular intrahepatic portosystemic shunt (tips) procedure in the gastroenterology department.Hepatic angiography was used to show the position of the portal vein and to puncture the jugular vein.The device was to be used for puncture between the hepatic vein and portal vein.However, after opening the packaging of the set, resistance between the flexor sheath and the 10 french black catheter/stiffening cannula combination was experienced, resulting in separation of the hub from the 10 french black catheter.The device was immediately replaced with a new liver access set with the same catalog number.The situation improved slightly, and the puncture was successfully performed.Subsequently, balloon dilation and stent implantation were performed.Procedural imaging confirmed smooth blood reflux and a decrease in portal vein pressure to the ideal range.Patient bandaged and safely returned to the ward.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The device was received by cook on 25-feb-2026.Preliminary visual examination revealed that the flexor sheath was unraveled, thus prompting this report.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation it was reported that the hub separated from the introducer catheter in a rosch-uchida transjugular liver access set.The transjugular liver access set was required for a patient undergoing a transjugular intrahepatic portosystemic shunt (tips) procedure in the gastroenterology department.Hepatic angiography was used to show the position of the portal vein and to puncture the jugular vein.The device was to be used for puncture between the hepatic vein and portal vein.However, after opening the packaging of the set, resistance between the flexor sheath and the 10 french black catheter/stiffening cannula combination was experienced, resulting in separation of the hub from the 10 french black catheter.The device was immediately replaced with a new liver access set with the same catalog number.The situation improved slightly, and the puncture was successfully performed.Subsequently, balloon dilation and stent implantation were performed.Procedural imaging confirmed smooth blood reflux and a decrease in portal vein pressure to the ideal range.Patient bandaged and safely returned to the ward.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The device was received by cook on 25feb2026.Preliminary visual examination revealed that the flexor sheath was unraveled, thus prompting this report.Reviews of documentation including the complaint history, device history record (dhr), specifications, and quality control procedures, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.One used set was received.The black catheter pulled free from its hub and was stuck inside the sheath.The catheter was able to be removed from the sheath with pliers.The sheaths hub was removed, and the inner coil appears to be unraveled.The outer diameter of the catheter was measured twice at three different locations throughout the length.The catheter measured out of specification.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 dhr for the reported complaint device lot and the related subassembly lots did not reveal any related quality control discrepancies.A complaint history search identified no other events reported for the related failure mode.Cook did not review product labeling.The manufacturer does not apply an ifu for this product.Instructions for use are applied by the local distribution partner.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concludes the cause of the event to be supplier manufacturing deficiency.A supplier corrective action was opened to further investigate this issue and remains ongoing.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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: 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: 24630044
• Report Number: 1820334-2026-00292
• Device Sequence Number: 9067973
• 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): 05/27/2026

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: 16840410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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: C TUBE; COOK BALLOON; GORE VIATORR STENT; TERUMO 5F PUNCTURE SHEATH; TERUMO LIVER TUBE; TERUMO MICROCATHETER
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 54 KG