MAUDE Adverse Event Report: COOK INC TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number N/A

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: maximum 9fr/guide 0.038 st jude medical.Pma/510(k) #: pre-amendment.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 transjugular liver access and biopsy needle set was used for a transjugular liver biopsy procedure.During the procedure, the physician attempted to insert the catheter for the needle into another manufacturer's introducer.The catheter was difficult to advance due to the material flaking as it was advanced through the introducer.Two more catheters from other identical sets were used with the same problem.The procedure was completed with another introducer.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information clarifying how the procedure was completed regarding the catheter has been requested but is currently unavailable.

Event Description

Clarification of event details received on (b)(6) 2018 noted that 3 rmt needle sets from cook were used during the procedure, while the introducer used was from competitor (b)(6).

Manufacturer Narrative

Additional information: the event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

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 unchanged, unknown or unavailable.Product received on: (b)(6) 2019.Investigation evaluation : a review of the complaint history, device history record, instructions for use, quality control, and specifications, as well as a visual inspection of the returned device, were conducted during the investigation.The complaint device was returned in a used and damaged condition.The visual inspection found a kink on the shaft of the catheter and white spots on the surface of the tubing.The white spots disappeared after rubbing and no material was found to be flaking or loose.The is no evidence to suggest the device was manufactured out of specifications.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.The appropriate personnel have been notified.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.

• Brand Name: TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7992125
• MDR Text Key: 126229306
• Report Number: 1820334-2018-03170
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002205215
• UDI-Public: (01)00827002205215(17)210614(10)8896130
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: N/A
• Device Catalogue Number: RMT-16-51.0-TJL
• Device Lot Number: 8896130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1