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.
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