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 Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 07/28/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: ir lab manager.G4 - 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 Description

It was reported the stiffening cannula of five ultrathane mac-loc locking loop multipurpose drainage catheter was difficult to remove.During the procedure.The metal stiffening cannula was getting "stuck" inside the drainage catheter and could not be removed.The procedure was complete with the same device but of a different lot number.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

The device was returned to cook.Upon receipt of the device, it was noted that the flexible stiffener was lodged inside the catheter, and the hub was missing.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: h6 - annex a correction: h6 - annex 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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation it was reported that the metal stiffening cannulas of five ultrathane mac-loc locking loop multipurpose drainage catheters were difficult to remove.During the procedure.The metal stiffening cannula was getting "stuck" inside the drainage catheter and could not be removed.The procedure was complete with the same device but of a different lot number.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Upon receipt of the devices for evaluation, it was noted that the flexible stiffener was lodged inside the catheter and the hub was missing.This report will address difficult removal of both metal and flexible stiffeners.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.A total of 4 ultrathane mac-loc locking loop multipurpose drainage catheter sets were returned.One was received in a used and damaged condition.The clear flexible stiffener was discovered to be within the ult12.0 catheter, missing the proximal hub.Upon removing the stiffener, the o.D.Was confirmed to be within specification.The i.D.(inner diameter) and o.D.(outer diameter) of the ult12.0 catheter were also confirmed to be within specification.Since the mentioned metal stiffener was not returned, the investigation was unable to verify the o.D.The remaining devices were opened, inserting and removing both supplied stiffeners (metal and flexible) from the catheters, encountering no difficulty.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 reviewed the device history record (dhr) for the reported lot and confirmed there were no relevant recorded nonconformances.One associated subassembly lot did show one relevant nonconformance, in which the devices were scrapped prior to further processing of the order, and remaining product in the lot underwent quality control activities.To date, a further search of our database records revealed no additional complaints have been received from the reported lot.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints from the field, cook has concluded that there is no evidence that non-conforming product exists in-house or in the field and that the device was manufactured to current specifications.Cook also reviewed product labeling.The product ifu, [t_multi2] ¿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.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not upset he 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 devices, and the results of the investigation, the cause for this event is traced 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 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: 17454735
• MDR Text Key: 320669140
• Report Number: 1820334-2023-01018
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097674
• UDI-Public: (01)00827002097674(17)260314(10)15274502
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024

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: ULT12.0-38-45-P-6S-CLM-RH
• Device Lot Number: 15274502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 01/23/2024
• Supplement Dates FDA Received: 12/15/2023; 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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