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

Model Number	G06929
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hub of the sheath in a rosch-uchida transjugular liver access set separated.During a tips (transjugular intrahepatic portosystemic shunt) procedure for a 67-year-old male patient, the hub of the sheath broke upon insertion/puncture of the sheath.The user retracted the device and used another like device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3 - device evaluated by mfg.? device evaluation anticipated but has yet begun.Awaiting device return.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5 correction: a2, a4 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
The description of the event was clarified on (b)(6) 2025.It was reported that the10f introducer sheath was inserted into the 10f/40cm sheath and punctured through the jugular vein.When the 10f introducer sheath was withdrawn, the 10f/40cm sheath broke at the caudal connection.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d4 - primary udi number; h6 - annex a, annex g.Investigation ¿ evaluation.It was reported that the hub of the flexor sheath in a rosch-uchida transjugular liver access set separated.During a tips (transjugular intrahepatic portosystemic shunt) procedure for a 67-year-old male patient, the hub of the sheath broke upon insertion/puncture of the sheath.The user retracted the device and used another like device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), and quality control, as well as a visual inspection of the returned device, were conducted during the investigation.One used flexor sheath was returned to cook for evaluation.Upon visual inspection, it was noted the sheath was torn above the hub.There was sheath material left in the hub.Cook has concluded that the device was manufactured to 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 dhrs for the reported complaint device lot and the related subassembly lots revealed no quality control discrepancies.A complaint history search identified one other event reported for a related failure mode.Additional related lots were reviewed and no discrepancies or complaints were found.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.The manufacturer does not apply an ifu for this product.Instructions for use are applied by the local distribution partner.Based on the available information, inspection of the returned device, and the results of the investigation, cook concluded the cause of event to be component failure unrelated to any manufacturing or design deficiencies.It is possible that as the different components were being advanced through the sheath, the sheath became damaged and separated.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 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 the patient and/or event 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: 22373097
• Report Number: 1820334-2025-00806
• Device Sequence Number: 12766623
• Product Code: DYB
• UDI-Device Identifier: 00827002069299
• UDI-Public: (01)00827002069299(17)270319(10)15956542
• 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): 01/12/2026

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: 15956542
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 12/29/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/15/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: EMBOLIZATION COIL - UNKNOWN MANUFACTURER AND MODEL.; GELATIN SPONGE GRANULE EMBOLIZATION AGENT.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG