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 Twisted/Bent (2981)

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

Event Date 06/12/2022

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer (person): phone:(b)(6).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 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

It was reported that, during the placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter in an unknown patient, the stiffening cannula was bent and could not be separated from the catheter.The catheter and cannula were removed together, and a new like device was used to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

Additional information was provided on 28dec2022 indicating that the metal stiffener was bent and could not be removed from the catheter.

Manufacturer Narrative

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

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 unchanged, unknown, or unavailable.Investigation ¿ evaluation.On 19dec2022, cook korea received a complaint from a representative at the (b)(6) hosp., located in the city of (b)(6) regarding the stiffener in an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-5s-cldm-hc: lot #: 13516065).It was reported that during placement of the catheter, the metal stiffener was discovered to be bent and could not be removed from the catheter.The catheter and stiffener were removed together, and a new like device was used to complete the procedure.No adverse effects to the patient were reported.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, quality control procedures for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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.In response to this incident, cook completed a review of the dhr.The dhr for lot 13516065, and all related subassembly lots, recorded one nonconformance for "incorrect fit" that was determined to be relevant to the reported difficulty.The devices were scrapped prior to further processing of the order.To date, a further search of our database records revealed no additional complaints associated with the reported lot.Cook also reviewed product labeling.The product ifu, [t_multi_rev5] ¿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.¿ the information provided upon review of the dmr, dhr, and ifu suggest that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no 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.

• 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: 16068001
• MDR Text Key: 307503929
• Report Number: 1820334-2022-01894
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

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 Expiration Date: 10/27/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-HC
• Device Lot Number: 13516065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 12/28/2022; 04/20/2023
• Supplement Dates FDA Received: 01/09/2023; 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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