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

Catalog Number	LABS-100-J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
It was reported during a transjugular liver biopsy using a liver access and biopsy set, the catheter became stuck inside the co-ax system and could not be withdrawn.After some manipulation of the device, the physician forcefully pulled it out and the tip sheared off.An additional procedure using a snare was performed for the retrieval of the tip through the groin.The retrieval was successful and a second kit was opened to continue with the transjugular biopsy.As reported, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Correction: age or date of birth & weight: asku; sex: male.Investigation: evaluation: conclusion codes: cause cannot be traced to device (4310); adverse event related to procedure (4311).A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/dimensional verification/functional test of the returned device were conducted during the investigation.Customer returned one stiffening cannula/trocar with a check-flo valve, a dark blue 7.0fr catheter/shaft/introducer.Additionally, the customer returned on 5.0fr catheter in a damaged condition.An additional 4.5cm light blue tubing was returned in a damaged and kinked state.Biomatter is present.Upon reintroduction of the light blue catheter, a dark liquid came out of the tip of the blue shaft and trocar.The catheter was inserted and removed with ease.The tip of the dark blue sheath is damage, pinched inward.There does not appear to be any other damage on the blue sheath.The light blue catheter likewise does not have any damage on the main portion, however the returned smaller portion is severely kinked.Bond from 5.0fr blue catheter to light blue tip is visible.The separation occurred 0.2cm after the tubing color change.There appeared to be biomatter on the trocar/stiffening cannula and biomatter in the check-flo, likely used.Additionally, it was noted that the torcon catheter passed dimensional testing also, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode as all related nonconformances were scrapped.It should be noted there were no other reported complaints for this lot number.Ifu t_labs warns.¿extreme care must be exercised during manipulation and withdrawal of catheter to prevent pulling catheter apart.¿ ifu states, ¿using standard access techniques, introduce an appropriate.035 inch wire guide into the inferior vena cava via jugular access.¿ ifu states, ¿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.¿ 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 the 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 catheters during removal through the metal stiffening cannula.Leaving a wire guide through the straight catheter during removal may aid in preventing catheter damage." ifu t_nbadv_rev0 and t_ce_angio88_rev5."precautions: due to thin wall construction, extreme care must be exercised during manipulation and withdrawal.Catheter insertion through a synthetic vascular graft should be avoided whenever possible.Instructions for use: if resistance is encountered during manipulation, stop and determine the cause before proceeding any further." based on the information provided, the examination of the returned product, and the results of our investigation, the possible root cause was determined to be an unknown issue during the procedure.We have notified the proper personnel about this event.Per the quality engineering 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.

• 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: 7635680
• Report Number: 1820334-2018-01739
• Device Sequence Number: 16598888
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)201206(10)8424488
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 12/06/2020
• Device Catalogue Number: LABS-100-J
• Device Lot Number: 8424488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 10/02/2018
• 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: Required Intervention