MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Deformation (2976)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported a 67-year-old male patient required replacement of an ultrathane mac-loc locking loop multipurpose drainage catheter for percutaneous transhepatic cholangio-drainage (pcd) under biliary digital subtraction angiography (dsa).The catheter was placed in the patient for biliary drainage.During the procedure, the puncture needle was withdrawn and the wire guide was inserted from the proximal end of the drainage catheter.Upon draining bile, the drainage catheter was found to have lateral leakage.Another catheter was used, and the procedure was complete successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional customer information: street: (b)(6).Phone# (b)(6).Customer occupation: "agent".Pma/510(k) #: exempt.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

Additional information: b5, d9, h6 (annexes a and g).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

Cook received the complaint device on 30sep2022.Visual inspection of the catheter showed leakage at the cap/mac-loc adaptor connection site.It was noted that the proximal flare was creased and torn.The suture was also broken.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation on 13sep2022, cook china received a complaint from a representative at the changsha senfu medical equip.Co.Located in the city of changsha, hunan province cn regarding an incident involving an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh; lot #: 14330492).A percutaneous transhepatic cholangio-drainage (pcd) under biliary digital subtraction angiography (dsa) procedure was performed on a 67-year-old male patient who required replacement of a catheter for biliary drainage.During the procedure, the puncture needle was withdrawn, and the wire guide was inserted from the proximal end of the drainage catheter.Upon draining bile, the drainage catheter was found to have lateral leakage.Another catheter was used, and the procedure was complete successfully.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, and manufacturing instructions, as well as functional test of the returned device, were conducted during the investigation.One used catheter was returned to cook for evaluation.The investigation confirmed the cap and mac-loc adapter passed the gap gauge requirement.During tabletop testing, a functional test confirmed fluid escaping at the cap and mac-loc adaptor connection site.The cap and mac-loc adaptor were disassembled, discovering the presence of a crease and tear in the flare.Based on the investigation results, it was determined the device was manufactured out of specification.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 14330492 and the related subassembly lots revealed no related non-conformances.An expanded search was conducted, and all lots manufactured by the same flaring operator and proximal assembly operator were reviewed.Six total complaints for leakage were identified and the corresponding lots were placed on stop ship.The information provided upon review of the returned device suggests that it was manufactured out of specification.Review of the dhr suggests that there are additional nonconforming devices in the field but not in house.Containment was performed on related lots.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi_rev5, multipurpose drainage catheter] with the device contains the following in relation to the reported failure mode: "precautions patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.How supplied upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned device, and the results of the investigation, the cause of this event was due to manufacturing deficiency.Based on the investigation findings, it was determined the flare was manufactured out of specification.The appropriate responsible manufacturing department was issued a defect awareness training.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: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 15465219
• MDR Text Key: 306424892
• Report Number: 1820334-2022-01514
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)241104(10)14330492
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 14330492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 09/30/2022; 03/16/2023
• Supplement Dates FDA Received: 10/07/2022; 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male