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

Model Number N/A

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

International customer reported that a patient was undergoing a transjugular liver biopsy procedure on (b)(6) 2017.The customer reports that the black catheter was dammed / punctured by the biopsy needle.The event occurred while the user was placing the needle into the catheter.There are no reports of any adverse events or need for medical / surgical intervention to prevent an adverse event.No further event or patient information was provided.The instructions for use cautions the user that "when introducing the needle through the catheter, the needle should be advanced over the wire guide in order to prevent catheter damage.".

Manufacturer Narrative

Corrected data: ¿the customer reports that the black catheter was damaged / punctured by the biopsy needle.¿ this sentence was erroneously transposed onto the initial report.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, documentation, instructions for use (ifu), manufacturing instructions, and quality control of the device were conducted during the investigation.One black catheter was returned in open and used condition.No needle/cannula was returned.There appears to be a needle puncture approximately 25 mm from the distal end of the catheter.No damage to the catheter was otherwise noted.The catheter was placed on the drawing curve template and it was determined that the curve was within tolerance.Since the needle component was not returned, no additional visual or dimensional analysis could be done.The work order for lot 7900568 was reviewed and revealed no non-conformances reported within the manufacturing department.Since the complaint involved the catheter and needle components of the product, the work orders for subassemblies ic7715692, ic7865258, and ni7900567 were also reviewed.There were no non-conformances reported for lot ni7900567.There was one non-conformance reported for lot ic7715692 for a dent/surface defect at distal end of the catheter and one device was scrapped and not replaced.There was one non-conformance reported for lot ic7865258 for curve not correct to template and one device was scrapped and not replaced.Both of these non-conformances are potentially related to the failure described.To date, a further search of the manufacturer's database records revealed this complaint to be the only reported complaint associated with the complaint lot number.The ifu states the following precaution, ¿when introducing the needle through the catheter, the needle should be advanced over the wire guide to prevent catheter damage.¿ it is possible that the needle was not inserted into the catheter over the wire guide.Without visual, dimensional, or functional testing of the involved needle component and without additional information, a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is required.We have notified the appropriate personnel and will continue to monitor for similar complaints.

• 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: 6811589
• MDR Text Key: 83295747
• Report Number: 1820334-2017-02356
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002205482
• UDI-Public: (01)00827002205482(17)200602(10)7900568
• 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,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RMT-15-51.0-TJL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• 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