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
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the inner stiffener of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was difficult to remove.While performing a nephrostomy, the radiologist attempted to remove the inner stiffener from the catheter and the entire catheter "bunched up (concertina effect)" in return.Another catheter was used and placed, successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Additional customer information: postal code: (b)(6).Initial reporter occupation: regulatory affairs manager.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.
Event or Problem Description
Per additional information, latex gloves were worn during the procedure.The patient did not have any pre-existing conditions.Lignocaine was administered and a small incision was made before insertion of catheter.The access site to the pleural space was the right side back between the rib cage.The patient has normal anatomy.The coating of the device was activated immediately by saline before inserting the catheter.Only cook devices were used during the procedure.The patient's outcome was to drain the excess fluid from the pleural space of the pleural effusion.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: on 17feb2023, a complaint from a representative at the facility marcus medical pty ltd, located in the city of johannesburg, za, was received by the cook european shared service center (essc).During an attempt to remove the metal stiffening cannula from the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-15-p-5s-cldm-hc, lot: 14897007) during a nephrostomy procedure, difficulty was encountered.Ultimately, the entire drainage catheter was removed and a new one was placed successfully.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), quality control procedures and specifications, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One open and used device was received for evaluation.The catheter was returned with the disposable stiffening cannula inserted.During table-top testing, the stiffening cannula was able to be removed from the catheter.When the stiffener was re-inserted into the catheter and again removed, no difficulty was encountered.A dimensional verification of the catheter inner diameter and stiffener outer diameter found that both were manufactured within specification.Upon a visual inspection, no evidence of surface defects was found.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 prior to distribution.A review of the device history record (dhr) for lot 14897007 and related subassemblies found no relevant nonconformances that could have contributed to the reported failure.It should be noted that there were no other complaints associated with the final product lot number.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: ¿1.Under fluoroscopic control, perform standard techniques for placement of percutaneous draining catheters, either by seldinger access or trocar access.2.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.¿ evidence gathered from a review of the dmr, ifu and dhr suggests 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, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified.Per the risk assessment no further action is required.Cook 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: 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: 16436502
• Report Number: 1820334-2023-00182
• Device Sequence Number: 11544952
• Product Code: GBO
• UDI-Device Identifier: 00827002113862
• UDI-Public: (01)00827002113862(17)250814(10)14897007
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2025
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-15-P-5S-CLDM-HC
• Device Lot Number: 14897007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 05/04/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/01/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown