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

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/10/2018

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).510k status: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The customer reported that during the use of the rosch-uchida transjugular liver access set used for a transjugular intrahepatic portosystemic shunt (tips) procedure, it was discovered that the flexor sheath did not have a radiopaque band.The customer did not keep the sheath for examination however, they checked two other sets with the same lot number under fluoroscopy which also did not have a radiopaque band.The case was completed successfully without incident.The patient did not experience any adverse effects due to this occurrence.The customer reported the devices are not available for return.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control and conducted during the investigation.Clinical assessment: per the health risk assessment, ¿the absence of the radiopaque band would most likely be easily detected with the appropriate medical imaging that would be required in performing an accurate placement of the introducer tip.The device would have to be removed and possibly replaced resulting in ¿low impact harm.¿ also, ¿conversely, it is possible that the absence of the radiopaque band could result in vessel trauma as the introducer tip is not visualized and the vessel is inadvertently damaged.The likely severity to the patient in this scenario is moderate harm resulting in prolonged hospitalization (minor).¿ at this time, the lack of radiopaque band visibility is probably manufacturing related.The devices were not returned.However, the customer provided pictures of the failure.The picture shows noticeable differences between the sheaths with and without the radiopaque marker.Due to these pictures, it has been confirmed there are three non-conforming devices (1 used and 2 unused) from lot 8395985.Additionally, a document-based investigation was performed.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.There is no evidence to support that other non-conforming devices are out in the field due to no other complaints being reported from this lot.Document review was able to find multiple procedures involved with manufacturing and inspecting which should prevent/identify this failure mode before being distributed to the customer.Based on the information provided and the results of our investigation, the likely root cause has been identified as manufacturing related.Appropriate measures have been initiated to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

Manufacturer Narrative

H2: follow up type: the investigation was reviewed and updated in response to an fda inquiry for this medwatch report.Changes are being submitted as corrections.The investigation evaluation has been described in full below.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control, documentation, and specifications of the device, as well as an image review and supplier investigation, were conducted during the investigation.A review of the provided imaging confirmed a significantly less radiopaque or absent radiopaque band, confirming the customer complaint.However, the devices could not be confirmed to be manufactured out of specification.Additionally, a document based investigation evaluation was performed.Sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) showed no related nonconformances or other complaints under any of the 24 lots traced to the same supplier lot at the time of this investigation.Compiling this information, nonconforming product is not suspected in house or in the field.A supplier investigation was requested.Quality controls, previous complaints, and nonconformances were reviewed.Manufacturing cause of failure was not suspected.Based on the information provided, the image review, and the results of the investigation, a definitive root cause could not be established.Per the quality engineering risk assessment no further action is required.Cook 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

The investigation was reviewed and updated.

• Brand Name: ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET
• Type of Device: GBZ CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7390655
• MDR Text Key: 104277765
• Report Number: 1820334-2018-00831
• Device Sequence Number: 1
• Product Code: GBZ
• UDI-Device Identifier: 00827002069299
• UDI-Public: (01)00827002069299(17)201122(10)8395985
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2019
• Patient Sequence Number: 1