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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported that the tip of a catheter included in the liver access and biopsy set separated during a liver biopsy procedure on an unknown patient sometime in 2011.The separated catheter tip was left in the body of the patient and was later discovered in the patient's lung.Additional information regarding event details has been requested, but is currently unavailable.

Manufacturer Narrative

Customer (person): postal code: (b)(6).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.

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

Additional information was provided on 27mar2022 and 31mar2022 indicating that the catheter used in the procedure was the one provided with the device.Further information has been requested from the manufacturer regarding the catheter.A 7 cm portion of the catheter was found in the patient's lung.The patient will require an x-ray to determine if the product is at fault as a part of a nsw health department investigation.

Manufacturer Narrative

Investigation ¿ evaluation.An issue was reported with a liver access and biopsy set (labs-100) from an unknown lot.Sometime in 2011, 7cm of the beacon tip catheter (hnbr5.0-38-80-p-ns-mpb) in the labs set separated and was found in the patient¿s lungs.Cook became aware of this event on 25feb2022 upon being notified by (b)(6) hospital.As of (b)(6) 2022, the patient has reportedly experienced no additional adverse effects as a result of this incident.Reviews of the complaint history, manufacturing instructions (mi), quality control, and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned; therefore, a physical examination could not be performed, and relevant dimensions could not be measured against specification.Capa (b)(4) was previously open to investigate the issue of bonded tip separation for beacon tip catheters.This capa found that 5.0fr beacon tip catheters most often experienced a single circumferential separation near the bond site.The reported complaint device fragment is 7cm long, and per the device drawing the bond site is 3.1cm from the distal tip.Based on this discrepancy, this event was determined to not be related to the capa and related recall.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.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document t_labs_rev4 [liver access and biopsy set] was packaged with this device at the time of the event.The product ifu states the following in consideration of the reported failure mode: "instructions for use 2.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." based on the available information, no product returned, and the results of the investigation, cook has determined a definitive root cause for this event could not be established.It is possible that the patient had tortuous anatomy which damaged the catheter upon advancement, but this cannot be confirmed with certainty.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 patient and/or event details 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: 13724728
• MDR Text Key: 290546629
• Report Number: 1820334-2022-00378
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LABS-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other