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

Catalog Number RMT-15-51.0-TJL

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that during use of the transjugular liver access and biopsy needle, the needle exhibited resistance when being advanced through the catheter and eventually became completely stuck, so the needle could not be removed.Furthermore, the outside of the catheter felt "ribbed" to the user.The procedure was completed with a new set, and there were no injuries or additional procedures.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7522311
• MDR Text Key: 108897325
• Report Number: 1820334-2018-01508
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002205482
• UDI-Public: (01)00827002205482(17)190628(10)7031523
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RMT-15-51.0-TJL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1