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

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required placement of a rosch-uchida transjugular liver access set for an unknown procedure.During flushing and prior to patient contact, the valve separated from the sheath.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

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

Manufacturer Narrative

Investigation - evaluation: (b)(6) trade co., ltd (china) informed cook that the valve of the flexor sheath in a rosch-uchida transjugular liver access set was separated.The customer reported that the device did not make patient contact and the failure occurred during flushing.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One separated flexor sheath was returned to cook for evaluation.Upon visual inspection, a small amount of coiling was noted to be exiting the proximal end of the sheath.The hub was separated from the tubing and biomatter was noted throughout the proximal fitting.The check-flo body and cap were disassembled; the flare was present in the check-flo body.The clear strain relief was present.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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot and the related component lot did not reveal any recorded non-conformances related to the failure mode.A database search did not identify any other events associated with the reported device lot.Given the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The instructions for use [t_rups_rev4] supplied with the device states the following in consideration to the reported failure mode: "warnings: -if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.-reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal o flexor sheath, consider carefully reinserting the dilator prior to continuing removal." based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event has been traced to component failure unrelated to a deficiency in manufacturing/device design.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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, 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.

• 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: 11185073
• MDR Text Key: 260756073
• Report Number: 1820334-2021-00104
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10827002069296
• UDI-Public: (01)10827002069296(17)230810(10)13359624
• Combination Product (y/n): N
• PMA/PMN Number: K171820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: N/A
• Device Catalogue Number: RUPS-100
• Device Lot Number: 13359624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1