MAUDE Adverse Event Report: COOK INC RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET; DYB INTRODUCER, CATHETER

Model Number	G29769
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 - device evaluated by mfg.? device evaluation anticipated but has not 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 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 ptfe catheter from a ring transjugular intrahepatic liver access and biopsy set exhibited some sheering during the procedure.The physician was inserting the colapinto needle into the sheath placed in the patient's right internal jugular vein, when some resistance and internal sheering of the sheath was noted.The sheath was removed, and a new set was opened to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding event details has been requested but is currently unavailable.
Additional Manufacturer Narrative
Additional information: b5; d9 - date returned to mfg.H3 - device evaluated by mfg.? 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 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
In additional information, received 19dec2025, it was reported that the physician did not bend or manipulate the needle.He noticed some shearing of the sheath and did not proceed."it did not enter the patient¿s body.".
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable.Upon review of the device failure analysis, it was determined that this event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.One black catheter and needle were received.The needle was able to advance through the length of the catheter with some resistance noted.No damage was noted to the surface of the distal tip of the catheter.A borescope was used to look inside the black catheter.There were multiple scratches noted throughout the length of the catheter.There is no evidence to suggest that this observed failure, material damage or deformation to the inside of the catheter, would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.
Event or Problem Description
This event no longer meets the qualifications for a reportable event.See h11.

• Brand Name: RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY 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: 23468858
• Report Number: 1820334-2025-01365
• Device Sequence Number: 21055359
• Product Code: DYB
• UDI-Device Identifier: 00827002297692
• UDI-Public: (01)00827002297692(17)280216(10)16467285
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: G29769
• Device Catalogue Number: RTPS-100-10.0
• Device Lot Number: 16467285
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 04/13/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/02/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2025
• 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 Sex: Male