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

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: preamendment.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 an unknown patient required placement of a liver access and biopsy set for an unknown procedure.During the procedure while removing the 5 french catheter, the hub dislodged.Additional information regarding event details has been requested but is currently unavailable.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information received on 14dec2021, it was confirmed that the reported hub separation occurred with the straight black catheter.The product was returned on 06jan2022 and also showed a slit 7 cm from the distal tip of the 5fr catheter, in addition to the hub separation.The distal tip of the blue sheath included in the set was also damaged.It was out of round and folded inward with no sharp edges.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Additional information: h6 (annexes a and g) investigation ¿ evaluation changi general hospital (singapore) informed cook on (b)(6) 2021 of an issue with a liver access and biopsy set ( rpn: labs-100-j; lot #13678138).The customer reported that the 5fr black catheter hub dislodged while pulling the device out.It is unknown how the procedure was completed or if there were any adverse effects.When the device was returned, cook discovered that the tubing was sheared.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One used set was received.The hub was separated from the 5fr black catheter.A slit was also noticed in the tubing 7cm from the distal tip.The id of the catheter hub measures within tolerance of the provided specification listed on the drawing.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 13678138 and related ic13417823 lot records no relevant non-conformances or complaints.Cook reviewed product labeling.The product ifu, [t_labs_rev7] ¿liver access biopsy set,¿ provides the following information to the user related to the reported failure mode: ¿warnings extreme care must be exercised during manipulation and withdrawal of catheter to prevent pulling catheter apart.Insertion through a synthetic vascular graft should be avoided whenever possible.Instructions for use -using a selective catheter and wire guide of choice, catheterize the right hepatic vein or an appropriate alternative hepatic vein branch.Leave the wire in a safe, distal position, and remove the catheter.Caution: to prevent cardiac arrhythmias, continuous cardiac monitoring is recommended while negotiating past the right atrium.-introduce and advance the transjugular introducer sheath and stiffening cannula over the wire guide into the selected hepatic vein.When introducing these components as a preassembled set, the included straight catheter may be used to facilitate introduction.Once the set is positioned within the hepatic vein, the straight catheter should be removed.Note: care should be taken to prevent damage to the straight catheter during removal through the metal stiffening cannula.Leaving a wire guide through the straight catheter during removal may aid in preventing catheter damage.¿ ¿how supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile is package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ evidence provided from the dmr, dhr, product labeling, and device evaluation, there is no indication the complaint device was manufactured out of specification.Cook did not identify any nonconforming material in house or in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to component failure.The customer stated that the 5fr catheter hub dislodged while being pulled out.It is possible that during removal, the catheter was pulled by the hub causing the separation.However, this cannot be confirmed without additional information.Upon device return it was noted that the black catheter tubing was sheared.It is possible that during removal through the metal cannula, the straight catheter was sheared.However, this cannot be confirmed without additional information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: LIVER ACCESS AND BIOPSY SET
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• 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: 12988837
• MDR Text Key: 286353007
• Report Number: 1820334-2021-02666
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)240110(10)13678138
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: N/A
• Device Catalogue Number: LABS-100-J
• Device Lot Number: 13678138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2021
• 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