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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: (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.
Event or Problem Description
As reported, a (b)(6) old patient required the use of a liver access and biopsy set for a liver biopsy procedure.During the procedure, a "faulty gesture" led to the rupture of the distal end of the biopsy catheter.The rupture led to a portion of the catheter separating and creating a foreign body within the patient.After an attempt to recover it, the foreign body migrated into the pulmonary arteries.The device was then visualized using conventional radiology and was successfully removed from the patient with use of interventional radiology.No other adverse effects were reported for this incident.
Event or Problem Description
Additional information received 24aug2020 stated that the blue catheter broke when the physician removed it from the rmt assembly.Two additional procedures were required to remove the fractured segment successfully.
Additional Manufacturer Narrative
Additional methods code: device discarded (4115).Investigation ¿ evaluation.(b)(6) (france) informed cook that on (b)(6) 2020, the biopsy catheter in a liver access and biopsy set separated and migrated to the patient's pulmonary artery.The 62-year-old patient was undergoing a liver biopsy procedure.During the procedure, a "faulty gesture" resulted in the biopsy catheter separating and migrating.The separated segment was visualized in conventional radiology and required two additional interventional procedures for successful removal.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There are appropriate controls in place to address this failure prior to distribution.The device is shipped with instruction for use (ifu) which 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 3.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.¿ a review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots found no nonconformances.A complaint database search found no additional complaints from the lot.Therefore, there is no evidence of nonconforming material in house or in the field.It was reported that a "faulty" gesture resulted in catheter separation.The instructions for use warn to withdraw the catheter through the stiffening cannula with care.It is possible that when the user withdrew the catheter through the guiding cannula, they inadvertently caused damage.Based on the limited information provided, no returned product for evaluation, and the results of the investigation, the cause of this event is unintended use error.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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.

• Brand Name: LIVER ACCESS AND BIOPSY SET
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10200178
• Report Number: 1820334-2020-01202
• Device Sequence Number: 16405352
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)230117(10)10274973
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2023
• Device Model Number: N/A
• Device Catalogue Number: LABS-100-J
• Device Lot Number: 10274973
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR