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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported than an unknown transjugular liver access and biopsy set catheter "came apart" during an unspecified procedure.It is currently unknown if the patient experienced any adverse effects due to this occurrence.The complaint device was returned to the manufacturer on 05may2023 for evaluation.During the preliminary device failure analysis, it was noted that the shaft of the 5fr catheter had separated approximately 58cm from the flare.The hub was separated from the flare upon return, and the flare was observed to be out of round.Additional information regarding event details and patient outcome have been requested but are currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.E3: assistant supply chain director-procedures.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 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 or that a death or serious injury occurred; nor is it admission 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 patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d- product identifier, d1, d4 - lot number, expiration date, udi, g4, h4, h6 - annex e.G4 ¿ pma/510(k) #: k171853.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 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 or that a death or serious injury occurred; nor is it admission 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 patient and/or event details has been received since the previous medwatch report was sent.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation (b)(6) hospital (united states) informed cook on 27apr2023 of an issue with a labs-100-j-01 (liver access and biopsy set) from lot 14793426.The customer stated the 5fr catheter came apart.Upon device return, it was noted it was the 5fr straight catheter.It is unknown how the procedure was completed or if there were any adverse effects.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.One used catheter was returned to cook for evaluation.The shaft of the 5fr catheter was separated at approximately 58cm from the flare.The separated segment was approximately 6cm in length.The flare pulled free from the hub; no material was left in the hub.The flare was out of round.The catheter was received with the hub already detached.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 dhrs for the reported complaint device lot 14793426 and the related subassembly lots revealed one possibly relevant non-conformance.All nonconforming devices have been scrapped and inspected 100% prior to further production.Since these 100% inspection procedures are in place and no other complaints have originated from this lot, there is no evidence that nonconforming product exists in house or in the field.A database search did not identify any other complaints associated with the reported complaint lot.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 -utilizing standard access techniques, introduce an appropriate.035 inch wire guide into the inferior vena cava via jugular vein access.-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.Caution: to prevent cardiac arrhythmias, continuous cardiac monitoring is recommended while negotiating past the right atrium.-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 the metal stiffening cannula.Leaving a wire guide through the straight catheter during removal may aid in preventing catheter damage.¿ based on the device master record, device history record, product ifu, and device failure analysis, 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, inspection of the returned device, and the results of the investigation, cook concluded the cause of event to be component failure unrelated to any manufacturing or design deficiencies.The customer stated the 5fr catheter came apart.It's possible excessive force was used when removing the device, however this cannot be confirmed without additional information.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.

• Brand Name: LIVER ACCESS AND BIOPSY SET
• Common Device Name: 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 ; 8123392235
• MDR Report Key: 16912694
• Report Number: 1820334-2023-00584
• Device Sequence Number: 2189016
• Product Code: DYB
• UDI-Device Identifier: 00827002574854
• UDI-Public: (01)00827002574854(17)250614(10)14793426
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/10/2023

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 Expiration Date: 06/14/2025
• Device Model Number: N/A
• Device Catalogue Number: LABS-100-J-01
• Device Lot Number: 14793426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 09/05/2023; 09/15/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/13/2023; 09/05/2023; 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• 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
• Patient Sex: Unknown