MAUDE Adverse Event Report: COOK INC RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY NEEDLE; GBZ CATHETER, CHOLANGIOGRAPHY

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: exempt.Occupation: ir tech.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a ring transjugular intrahepatic liver access and biopsy needle was used during a transjugular intrahepatic portosystemic shunt procedure.When attempting to angle the needle into the target site, the needle would not turn (no difficulty with insertion per the customer).The device was removed from the patient and the needle tip separated into the sterile field.No portion of the device remained in the patient.The procedure was completed by using another needle.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.One used rmt needle with a slight presence of biological matter was returned for evaluation.No surface damage was noted along the catheter or cannula.The proximal hub of the cannula was returned separated from the device and solder was present at the region of separation.The device passed manufacturing specifications that pertain to this failure, suggesting that there is no evidence the device was not manufactured to specifications.Additionally, a document based investigation evaluation was performed.It has been found that there are sufficient controls in place to detect the sheath tip failure mode prior to device release to the customer.A review of the device history record showed no relevant nonconformances that could have contributed to this failure mode.It should be noted that there were no other complaints reported for lot 9078493 or component lots.The instructions for use (ifu) advise the user to inspect the device prior to use to ensure that no damage has occurred.Based on the information provided, examination of the returned product and the results of our investigation, the root cause could possibly be related to the manufacturing of the device and a quality control deficiency.During the soldering process of the hub to the cannula, if a complete connection was not made, it could cause an inadequate seal that may lead to a separation if torsional force is applied.Also, if the user held the catheter too tight while trying to twist the needle, the needle would be difficult to twist.Adding then excessive torque to the hub to try and twist the needle could result in the solder joint breaking, causing the hub to separate.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar events.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: RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY NEEDLE
• Common Device Name: GBZ CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8042768
• Report Number: 1820334-2018-03315
• Device Sequence Number: 1262876
• Product Code: GBZ
• UDI-Device Identifier: 00827002314788
• UDI-Public: (01)00827002314788(17)210808(10)9078493
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2021
• Device Model Number: N/A
• Device Catalogue Number: RMT-16-50.5-RTPS-100-10.0
• Device Lot Number: 9078493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1