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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.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) year-old male patient required a rosch-uchida transjugular liver access set for a transjugular intrahepatic portosystemic shunt (tips) procedure.When the user opened the package, the flexor sheath hub was separated form the tubing.The user used a new set to complete the procedure successfully.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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.(b)(6) (china) informed cook that on (b)(6) 2021, the flexor sheath in a rups-100 (rosch-uchida transjugular liver access set) from lot 13274174 was separated.The user noted that the proximal hub was separated from the sheath tubing when they opened the packaging.A new device was used to complete the procedure successfully.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 used rups-100 set was returned to cook for evaluation.Visual inspection of the device revealed that the blue catheter is torn near the distal tip.The stylet is covered in biomatter and a white crystal-like substance.The blue catheter was flushed and the trocar stylet was inserted, allowing the stylet to fully advance.A section of the dried crystal-like material exited the blue catheter.The material is likely imaging contrast and/or saline.The returned flexor sheath is missing the check-flo valve, which wasn't returned.Coil was exiting the proximal end of the sheath material and the flare was not 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 dhrs for the reported complaint device lot (13274174) and the related subassembly lots revealed one related nonconformance for "flare, inadequate"; however, it should be noted that the flare is 100% inspected during manufacturing.A database search did not identify any other reported events associated with this reported failure mode.Based on the information provided, 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 of 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.Appropriate measures have been taken to address this failure mode.A capa was previously opened to further investigate this failure mode with this device and found that the device is unable to be advanced into restrictive anatomy, potentially causing separation upon removal.It also found that reinsertion of the dilator prior to removal should be performed, as listed in the ifu.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: 11288205
• MDR Text Key: 257967087
• Report Number: 1820334-2021-00268
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10827002069296
• UDI-Public: (01)10827002069296(17)230630(10)13274174
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: RUPS-100
• Device Lot Number: 13274174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 60