MAUDE Adverse Event Report: COOK INC LIVER ACCESS AND BIOPSY SET; DYB INTRODUCER, CATHETER

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  malfunction  

Event Description

It was reported the "inner dilator" within a liver access and biopsy set sheered off during a transjugular liver biopsy procedure.During the case, a piece of the inner dilator sheered off.Another, similar device was used to complete the procedure successfully.Additional information regarding the event and patient outcome has been requested but is currently unknown.

Manufacturer Narrative

Pma/510(k) #: k171853.A follow up report will be submitted should additional relevant information become available.

Event Description

Additional information provided on 22mar2022 clarified the user had difficulty removing the sheath and dilator from the body.Upon removal, the sheath and dilator were separated, flushed, and reassembled.Prior to re-insertion of the device, it was noticed that the black dilator tip was damaged.Upon removal of the dilator from the sheath, it was discovered that a piece of the dilator had sheared off within the blue sheath.No fragment of the device was inside the patient's body.

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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation (b)(6) hospital (united states) informed cook medical on 15dec2021 of an issue with a liver access and biopsy set (labs-100-j-01) from an unknown lot.The customer stated that during a transjugular biopsy, the desired location to perform the procedure was not able to be reached due to the position of the device in the body.The blue sheath and black catheter were removed from the body, separated, flushed, then re-assembled.Upon inspection prior to re-inserting the device in the body, it was noticed by the physician that the black catheter tip was damaged.The catheter was removed from the sheath and a piece of the catheter was sheared off into the sheath.No fragment of the device was found inside the patient's body.The procedure was completed with a replacement device.A review of the documentation including quality control procedures, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used liver biopsy set was returned to cook for evaluation.Upon visual inspection, a 5cm piece was sheared off from the black catheter.The sheared piece started approximately 5mm from the distal tip of the black catheter.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.Cook did identify five possible lot numbers associated with this rpn and found no related nonconformances or complaints.Based on this information, the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [t_labs2_rev1] ¿liver access and 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.Instructions for use 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 (if applicable) 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 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 if package is unopened and 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.¿ based on the information provided, inspection of the device, and the results of the investigation, cook concluded the cause of event could not be established.The customer stated that during the liver biopsy, the black catheter was sheared while being inserted into the blue introducer sheath.It is possible the metal cannula sheared the black catheter during the procedure, though this cannot be confirmed.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: DYB INTRODUCER, CATHETER
• 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 ; 8128294891
• MDR Report Key: 13112057
• MDR Text Key: 284376221
• Report Number: 1820334-2021-02749
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: LABS-100-J-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2022
• 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