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

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: lead tech.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a (b)(6) old male patient required a rosch-uchida transjugular liver access set for a transjugular intrahepatic portosystemic shunt (tips) procedure.Prior to patient contact, it was noticed that the sheath tip was "defective." another device of the same kind was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation, there was no failure of the sheath.The user clarified that they experienced difficulty advancing the black catheter.Examination of the returned product showed no damage to the black catheter.The is no information confirming device malfunction or serious injury.Replacement of a device to complete procedure is negligible harm and does not meet the criteria for a reportable event.A review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.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

Additional information received 20jul2020.Upon return of the device for evaluation the returned black catheter had no visible damage noted.The customer clarified that the failure was difficulty in advancing the black catheter into the jugular vein after dilation occurred.

• 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
• MDR Report Key: 10189147
• MDR Text Key: 196417616
• Report Number: 1820334-2020-01178
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10827002069296
• UDI-Public: (01)10827002069296(17)220615(10)9815794
• Combination Product (y/n): N
• PMA/PMN Number: K171820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: N/A
• Device Catalogue Number: RUPS-100
• Device Lot Number: 9815794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR