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

Catalog Number LABS-100-J

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 a liver access and biopsy set was used during a transjugular liver biopsy and the sheath would not advance.The device became lodged and was difficult to remove, however, the operator used excessive force to remove it successfully.Upon examining the device, the black introducer had broken off and was lodged in the end of the sheath.Another like device was opened and used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: device available for return: yes; product received on: 27jun2018.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/dimensional verification of the returned device were conducted during the investigation.Customer returned one labs set in a damaged conditions and partially assembled.The blue sheath had a trocar fully inserted, the torcon catheter fully inserted, and a portion of the black catheter extending out of the distal tip.Customer also returned approximately 62cm of the black catheter beginning with the flare and ending with a tear.They also returned one connected 5fr hub and cap.It is likely the flare came from this hub.Biomatter is present on or within every component of the device.Upon attempting to pull out the torcon catheter, it was revealed that it had separated approximately 27.5 cm from the proximal hub.The remaining portion was pulled out the distal end.The 2nd portion of the torcon catheter is approximately 52cm in length.Other than the tear, there does not appear to be any damage to on the torcon catheter.However, the tear appears as if the catheter was pinched before separating, possibly due to the bend in the blue sheath.The location of the separation roughly lines up with the bend and tear in the sheath.Approximately 14cm from the hub on the blue sheath, there is severe damage.The sheath is completely disconnected on one side and hanging off on the other.There is no other surface damage.Upon removal of the trocar from the blue sheath, it is revealed that the trocar has snapped as well.Trocar was noted to have snapped 15cm form the proximal hub.The remaining portion of the trocar can be felt in the blue sheath.No other damage was noted on the trocar.The separated portion of the black catheter was measured 5.5cm in lengths.The catheter tubing appeared ripped.As described in the event description, it looks as if the catheter was pulled apart with excessive force.There does not appear to be any damage other than separation and the flare.The flare appeared to be warped, lopsided, and non-concentric." dimensional analysis of the device revealed that all components had been manufactured to the correct specifications and tolerances, therefore it is unlikely that the root cause is manufacturing related.It should be noted that the wire guide used during the procedure did not come within the cook labs-100-j set.A 0.035" j-tip wire guide from angiodynamics was used instead.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The device history review revealed nonconformances reported for the main device lot for incorrect labeling and foreign matter.The straight, angiographic catheter subassembly demonstrated a nonconformance for missing glue.No nonconformances were reported for the biopsy needle subassemblies.The torcon catheter subassembly demonstrated no reported nonconformances.All affected devices were identified and reworked out prior to device release.It should be noted there were no other reported complaints for this lot number.It was noted in the failure analysis of the device that the light blue catheter appeared to be inserted into the blue sheath during the procedure at the same time as the black catheter.Insertion of the torcon catheter at the same time as the straight catheter does not follow the correct ifu for the device.It is likely that both catheters do not easily fit within the sheath.Upon attempts to remove the straight catheter, it was likely to have gotten stuck due to the pressure of the insertion of both catheters.It is further noted in the ifu to be careful when removing the straight catheter in order to prevent damage from occurring.Excessive force was needed to remove the catheter, which could have caused the stuck catheter to be ripped apart.Although these instances cannot be confirmed, due to the observations during failure analysis, the possible cause of this failure is traced to the user.Based on the information provided, the examination of the returned product, and the results of our investigation, the possible root cause has been determined to be cause traced to user (failure to follow instructions).The appropriate personnel will be notified and we 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: 7560042
• MDR Text Key: 109762421
• Report Number: 1820334-2018-01658
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)201117(10)8383815
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LABS-100-J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANGIODYNAMICS J TIP WIRE 035: H787055003021; ANGIODYNAMICS J TIP WIRE 035: H787055003021