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

Model Number N/A

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Customer person: postal code: (b)(6) mobile: (b)(6).Pma/510(k) #: pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required a labs-100-j for an unspecified procedure.During the procedure, the black catheter was "shaved" by the biopsy needle.The patient is reportedly "fine, no issue." additional information about the event and patient outcome have been requested but is currently unknown.

Event Description

In additional information received on 30jun2021, it was reported that the inner black catheter was "sheared" during a transjugular liver biopsy procedure.

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.

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

The complaint device was returned to cook on 14jul2021.It was noted that the black catheter is split as it exits the cannula and the hub missing from the catheter.

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 20sep2021.The access site was the right internal jugular vein.The right hepatic vein was accessed to puncture the liver.There were no anatomic difficulties in gaining access to the organ.A second needle was opened after the first one failed and exibited the same failure during the same procedure.The catheter shaft was shaved by the large colapinto needle.The "shear" was identified when attempting to remove the black inner sheath, it could not be removed smoothly.The transjugular approach was aborted after the failure.No force was exerted on the separated hub of the introducer.The equipment was reported to have been used per instructions for use (ifu), following the steps per ifu.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) hospital (singapore) informed cook that on 16jun2021, the black catheter in a liver access and biopsy set (rpn: labs-100-j, lot: 13099332) was shaved after being withdrawn through the guiding cannula.After the first failure, a second device was opened, and the failure occurred again.The transjugular approach was aborted after the two failures.It is reported that the patient did not suffer adverse effects due to this incident.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control procedures, as well as a visual inspection, dimensional verification, and functional test of the returned device, were conducted during the investigation.Two used guiding cannulas were returned for evaluation.Hub separation in both black catheters was noted.Splits in the black catheters were noted as they exited the cannulas.Dimensional analysis confirmed that the devices and components were manufactured to the correct specifications and tolerances.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 lot 13099332, sheath component lot ic13016199, as well as needle component and subassembly lots ic10343510, sa10278385 and sa10278386, found no nonconformances that could have contributed to the reported failure.It should be noted that there was an additional complaint associated with the final product lot number; however this complaint is from the same facility for the same procedure.The failures were found to be unrelated.Cook also reviewed product labeling.The product ifu, [t_labs_rev7] ¿liver access and biopsy set,¿ provides the following information to the user related to the reported failure mode: instructions for use: ¿3.-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.¿ how supplied: ¿-upon removal from package, inspect the product to ensure no damage has occurred.¿ evidence gathered from reviews of the dmr, dhr, device failure analysis, and design history file, suggest that there is no indication the device was manufactured out of specification.There is no evidence of 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 contributed the reported event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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 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: 12068540
• MDR Text Key: 258608542
• Report Number: 1820334-2021-01606
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)230331(10)13099332
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: LABS-100-J
• Device Lot Number: 13099332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2020
• 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
• Treatment: UNKNOWN MANUFACTURER AMPLATZ WIRE
• Patient Age: 67 YR
• Patient Sex: Female