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

Catalog Number LABS-200

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

During a liver biopsy procedure, the medical doctor put the black straight catheter through the metal stiffening cannula to access hepatic vein.When trying to push into place, the hub came off the black catheter.The md had to remove lack catheter from metal cannula with hemostat.Md was able to get access with another catheter in the set and completed the biopsy.The patient did not require additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event is still under investigation.

Manufacturer Narrative

A review of complaint history, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.Product was returned in an opened and used condition.A visual inspection noted that the t5.0 straight catheter had separated from the hub.The flare on the proximal end of the catheter appeared stretched and uneven.There is no evidence to suggest that the product was not manufactured to specifications.This product is shipped with an instructions for use, which states under warnings- "extreme care must be exercised during manipulation and withdrawal of catheter to prevent pulling catheter apart " it is possible that the catheter was exposed to forces beyond its design, causing this failure mode to occur.Quality engineering risk assessment was used to assess the risk of the complaint.No risk reduction is required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

• Brand Name: LIVER ACCESS AND BIOPSY SET
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4236561
• MDR Text Key: 4975178
• Report Number: 1820334-2014-00576
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LABS-200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/16/2014
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention