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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: unknown.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 Description

It was reported a liver access and biopsy set was used for a transjugular intrahepatic liver biopsy in an unknown patient.During the procedure, the metal stiffening cannula was broken while changing position in the hepatic vein.As reported, the broken piece was advanced through the catheter.The hub was cut from the sheath and the broken cannula fragment was safely removed.The patient did not suffer any harm and the procedure was completed with a new set.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

No additional patient or event information has been received since the last report was submitted on 01aug2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection and dimensional verification of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, quality control, and specifications.The complainant returned the stiffening cannula to cook in a used and damaged condition.Inspection of the returned stiffening cannula confirmed the device was used and damaged.Two bends were noted on the shaft approximately 18cm and 37cm from the proximal fitting.The tubing is fractured 39.7cm from the fitting.The cross-section of the fracture was out of round and was shaped like a semicircle with the flat edge of the semicircle facing the same direction as the baseplate arrow.Relevant dimensions such as outer and inner diameter of the stiffening cannula were measured to be within specification.Additionally, a document based investigation evaluation was performed.Sufficient controls are in place to detect this failure mode prior to release.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Since there are no related non-conformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.Based on the information provided, the examination of returned product and the results of the investigation, it was concluded that a component failure unrelated to design or manufacturing causes contributed to this event.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
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8851514
• MDR Text Key: 175674854
• Report Number: 1820334-2019-01890
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)220306(10)9573455
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: N/A
• Device Catalogue Number: LABS-100-J
• Device Lot Number: 9573455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1