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

Model Number	N/A
Medical Device Problem Codes	Flaked (1246); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age: patient was in their 60's.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 male patient required a ring transjugular intrahepatic liver access and biopsy set for a transjugular intrahepatic portosystemic shunt (tips) procedure.On the back table, the needle was loaded over the wire and some of the coating of the wire came off inside the needle.No coating flakes entered the patient.A second amplatz was opened for femoral access using an ultrasound device 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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: (b)(6) medical center in (b)(6), usa informed cook of an occurrence involving an rtps-100-10.0 (ring transjugular intrahepatic liver access and biopsy set) from lot 13529947.The complaint stated there were shavings that came off the wire when they were trying to load the needle over the wire.The wire was pulled and a new wire used.The procedure was completed with the complaint device.There were no adverse effects to the patient due to this occurrence.Reviews 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 device were conducted during the investigation.The needle cannula and black catheter combination were returned for evaluation.The wire was not returned.A visual inspection of the needle cannula and black sheath/catheter found no damage or evidence of shavings.Biological matter was present on the distal end of the needle cannula.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that there are sufficient controls in place to address the reported failure mode.A review of the device history record (dhr) for lot 13529947 found no related nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot number.Cook also reviewed product labeling.The current instructions for use [t_trps_rev5] state the following: "instructions for use 2.Using the selective hepatic catheter and a wire guide of choice, catheterize the right hepatic vein (rhv) or the most adequate hepatic vein branch.Leave the wire guide in a safe, distal position and remove the catheter.3.Advance the transjugular introducer sheath assembly over the wire guide as distal as possible into the hepatic vein.Remove the wire and dilator.4.Insert the colapinto needle into the ptfe catheter, and introduce the catheter/needle assembly through the sheath.The needle should not protrude past the catheter end hole." the information provided upon review of device master record, device history record, device failure analysis, and instructions for use, suggests the device was manufactured to specification and that there are no nonconforming devices from this lot in house or in the field.It was reported that the physician advanced the needle over the wire.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a failure to follow instructions contributed to the event.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.

• Brand Name: RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET
• Common Device Name: 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: 11362213
• Report Number: 1820334-2021-00376
• Device Sequence Number: 14495749
• Product Code: DYB
• UDI-Device Identifier: 00827002297692
• UDI-Public: (01)00827002297692(17)231203(10)13529947
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K171820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: 12/03/2023
• Device Model Number: N/A
• Device Catalogue Number: RTPS-100-10.0
• Device Lot Number: 13529947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male