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

Model Number N/A

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 Description

It was reported that the sheath included in the rosch-uchida transjugular liver access set was difficult to place during a transjugular intrahepatic portosystemic shunt (tips) procedure.Upon withdraw of the device, the shaft of the flexor sheath separated from the check flo valve.The device did not unravel.There was no damage to patient anatomy, but the skin at the access site was "slightly damaged" due to repeated manipulation.A new same device was used to complete the procedure.The patient did not experience any adverse effects or additional procedures due to this occurrence.

• Brand Name: ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET
• Type of Device: 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: 19100468
• MDR Text Key: 340349833
• Report Number: 1820334-2024-00518
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10827002069296
• UDI-Public: (01)10827002069296(17)261115(10)15759781
• Combination Product (y/n): N
• PMA/PMN Number: K171820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RUPS-100
• Device Lot Number: 15759781
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male