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

Model Number	G50779
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the catheter included in the liver access and biopsy set was found torn inside the introducer sheath during a liver biopsy procedure.The physician initiated the procedure by puncturing right internal jugular vein without any complications, and a 9fr/25cm introducer sheath from a competitor was inserted.Pressure measurements were successfully performed using a competitor¿s balloon catheter.The check flow performer introducer sheath from the labs set was introduced over a competitor¿s amplatz guidewire with 1 cm flexible tip.Following the placement of the performer sheath, the doctor attempted to remove the straight black catheter and the guidewire, but a significant resistance was noticed.The straight catheter could not be withdrawn.During this attempt, the luer lock connector of the catheter detached.The entire labs set was then removed from the sheath for inspection.Upon examination, a slit in the catheter sheath was clearly visible.The doctor reintroduced the check flow performer sheath using a 5 fr vertebral catheter, which was positioned successfully.However, while attempting to withdraw catheter, resistance was again noted.The check flow performer sheath, along with the catheter and guidewire, was removed from the patient.Upon inspection, it was found that the tip of the 5 fr catheter was hooked onto the tip of the check flow performer sheath.Closer examination revealed that the performer sheath did not correctly encase the metal core.Photos provided by the customer show the shearing/split black catheter.A photo also shows that the hub separated from the black catheter.Imaging from the procedure was also provided.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The patient¿s anatomy had branching of the hepatic vein from the vena cava angled at almost 90 degrees.Otherwise, it had normal vascularization.
Additional Manufacturer Narrative
G4 - pma/510(k) #: preamendment h3 - device evaluated by mfg? device evaluation anticipated but not yet begun.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.
Additional Manufacturer Narrative
Investigation ¿ evaluation it was reported that the tip of the catheter included in the liver access and biopsy set was found torn inside the introducer sheath during a liver biopsy procedure.The physician initiated the procedure by puncturing right internal jugular vein without any complications, and a 9fr/25cm introducer sheath from a competitor was inserted.Pressure measurements were successfully performed using a competitor¿s balloon catheter.The check flow performer introducer sheath from the labs set was introduced over a competitor¿s amplatz guidewire with 1 cm flexible tip.Following the placement of the performer sheath, the doctor attempted to remove the straight black catheter and the guidewire, but a significant resistance was noticed.The straight catheter could not be withdrawn.During this attempt, the luer lock connector of the catheter detached.The entire labs set was then removed from the sheath for inspection.Upon examination, a slit in the catheter sheath was clearly visible.The doctor reintroduced the check flow performer sheath using a 5 fr vertebral catheter, which was positioned successfully.However, while attempting to withdraw catheter, resistance was again noted.The check flow performer sheath, along with the catheter and guidewire, was removed from the patient.Upon inspection, it was found that the tip of the 5 fr catheter was hooked onto the tip of the check flow performer sheath.Closer examination revealed that the performer sheath did not correctly encase the metal core.Photos provided by the customer show the shearing/split black catheter.A photo also shows that the hub separated from the black catheter.Imaging from the procedure was also provided.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The patient¿s anatomy had branching of the hepatic vein from the vena cava angled at almost 90 degrees.Otherwise, it had normal vascularization.Reviews of the documentation, including the complaint history, device history record (dhr), 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 set was received.The metal cannula was returned advanced through the sheath.The shaft of the black catheter was sliced approximately 5.5cm from the distal tip.The stiffening cannula extends out of the distal tip of the sheath approximately 1mm.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) for the device lot and related subassembly lot found no relevant nonconformances that could have contributed to the reported failure.It should be noted that there was one other complaint associated with the final product lot number for a different failure mode.Product labeling review: the product ifu, [t_labs_rev7] ¿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 selective 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.¿ evidence gathered upon review of the dmr, product ifu, dhr, 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, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.It¿s possible that the patient anatomy contributed to the failure mode, resulting in damage to the catheter, however this cannot be confirmed without additional information.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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 or Problem 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
• Common Device Name: FCG, BIOPSY NEEDLE
• 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: 22307946
• Report Number: 1820334-2025-00751
• Device Sequence Number: 8586618
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)270405(10)15993694
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G50779
• Device Catalogue Number: LABS-100-J
• Device Lot Number: 15993694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5 FR VERT CATHETER.; 9FR/25CM TERUMO INTRODUCER SHEATH.; BERENSTEIN BALLOON CATHETER.; BOSTON SCIENTIFIC AMPLATZ-SUPERSTIFF-GUIDEWIRE.
• Patient Sex: Unknown