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

Model Number N/A

Device Problems Unraveled Material (1664); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

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 an unknown patient required a ring transjugular intrahepatic access set for a transjugular intrahepatic portosystemic shunt procedure.Prior to patient contact, it was noted the sheath tip was damaged.On (b)(6) 2021, the customer provided a photo which showed an unraveled flexor sheath.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation chosun university hospital (republic of korea) contacted cook on (b)(6) 2021 to report that they received an rtps-100 from lot# ns9229792 with a damaged sheath tip.The procedure was transjugular intrahepatic portosystemic shunt.No part of the device was left inside the patient, and another device was used to complete the procedure.The patient did not experience any adverse effects due to this occurrence.A review of the documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control procedures, as well as a visual inspection of the returned product was conducted during the investigation.One sealed rtps-100 was returned for evaluation in an opened, unused condition.Upon a visual inspection, the distal end of the sheath was found to be split, with the inner coil unraveled.Approximately 1cm from the distal tip, delamination was noted within the sheath.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 device history record (dhr) for lot ns9229792 and subassembly lots ic8620445 and ic8933441 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with lot ns9229792.Based on the device master record, device history record, and device failure analysis, there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.The instructions for use (ifu) t_rtps_rev5 state that upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, examination of the returned product and the results of our investigation, a definitive cause for the reported failure could not be established.A capa to investigate this failure is currently open.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: RING TRANSJUGULAR INTRAHEPATIC 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: 11545316
• MDR Text Key: 244411052
• Report Number: 1820334-2021-00991
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10827002065410
• UDI-Public: (01)10827002065410(17)211011(10)NS9229792
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: N/A
• Device Catalogue Number: RTPS-100
• Device Lot Number: NS9229792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2018
• 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