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

Model Number N/A

Device Problems Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported an 82-year-old, 60 kg male patient required an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for an unspecified procedure.The bile duct was punctured with a 21-gauge needle.After removing the guiding sheath, advancing the drainage catheter along the wire guide, and flushing the device, the catheter could not be separated or removed from the needle core.After many attempts and applying a large amount of external force, the drainage catheter became deformed.The device was removed, and a new drainage catheter was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Additional customer information: line 2: chikangqiao community.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

Investigation ¿ evaluation: on 04nov2022, cook china received a complaint from a representative at the yunnan zhuoluan trading co.Ltd facility, located in the city of kunming city cn.Upon inserting the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult7.0-35-25-p-5s-cldm-hc; lot #: 14746453) over an.035" wire guide, the metal stiffening cannula could not be removed from the drainage catheter.After many attempts to remove the stiffening cannula, the drainage catheter became deformed, resulting in the removal of the entire device.A new drainage catheter was used to complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The customer returned a total of four devices having a product label lot of 14746453.One was received in a used condition, with the remaining three packages sealed and sterile.The used device was returned with the metal stiffener inserted into the catheter.Biological matter was observed to be present on the catheter.The stiffening cannula was confirmed to be stuck within the catheter.The distal tip of the catheter was manipulated, which released the stiffener.Upon the removal of the stiffener.No damage was present to the catheter and/or stiffener.The catheter tubing was cut to obtain inner and outer diameter measurements, confirming both to be within specification.The remaining packages were opened, encountering no difficulty encountered when inserting and/or removing the metal stiffener from the drainage catheter.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also completed a review of the dhr.The dhr for lot 14746453 confirmed there were no relevant recorded nonconformances.The catheter shaft sub-assembly lots had one relevant recorded nonconformance for "components, incorrect fit" having a quantity of two.These devices were scrapped prior to further processing of the order.All other subassembly lots had no relevant recorded nonconformances.Since there is objective evidence the dhr was executed, and there are no additional field complaints on this lot.Cook did not find evidence of nonconforming material in house or in the field.Cook concluded that the device was manufactured to specification.Cook also reviewed product labeling.The product ifu, [t_multi2_rev1] ¿multipurpose drainage catheter,¿ provides the following information to the user related to the reported failure mode: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ instructions for use: ¿under fluoroscopic control, perform standard techniques for placement of percutaneous draining catheters, either by seldinger access or trocar access.-once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to for its configuration.¿ how supplied: ¿supplied sterilize by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.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, it was determined the cause of this event is related to a component failure without a manufacturing or design deficiency.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.

Event Description

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

• Brand Name: ULTRATHANE DAWSON-MUELLER 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: 15756071
• MDR Text Key: 307698947
• Report Number: 1820334-2022-01711
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002110205
• UDI-Public: (01)00827002110205(17)250523(10)14746453
• 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
• Report Date: 03/07/2023

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: ULT7.0-35-25-P-5S-CLDM-HC
• Device Lot Number: 14746453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 60 KG