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 Problem Leak/Splash (1354)

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

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Catalog #: ult10.2-38-25-p-5s-cldm-tong-050399 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 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 an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked at the mac-loc hub lever.The failure was discovered before proceeding.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding event details has been requested, but is currently unavailable.

Event Description

In additional information received on 15sep2022, it was reported that leakage was noted upon completion of the procedure.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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

In additional information received on 07oct2022, it was confirmed that the device was used in the patient.Abdominal placement of the device was completed in the operating room.The issue was recognized during flushing operations prior to use on the patient.There was a small amount of leakage near the mac-loc lever area, but the operation proceeded.The procedure was completed, and the product was rechecked for leaks by flushing.No resistance was experienced during insertion or removal of device components.No force was exerted on 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 (b)(6) 2022, cook korea received a complaint from a representative at the seoul nat.Univ.Bundang hosp., located in the city of seongnam-si, gyeonggi-do, korea regarding an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-5s-cldm-tong-050399; lot #13296583).Leaking near the mac-loc lever area of the catheter was observed prior to patient contact, but the operation proceeded.Abdominal placement of the device was completed, and the product was rechecked for leaks by flushing.No resistance was experienced during insertion or removal of device components.No force was exerted on the catheter.It was confirmed that the device was used on the patient.The device is not available for return.No adverse effects or additional procedures were reported for the patient.Reviews of the complaint history, device history record (dhr), drawings, instructions for use (ifu), manufacturing instructions, and 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, 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.A review of the device history records (dhrs) for the lot 13296583 and related subassembly lots revealed no relevant non-conformances.This device is 100% inspected for this failure in process.There are no additional complaints on the reported lot.There is no evidence of manufacturing deficiency.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi_rev5, multipurpose drainage catheter] states the following in relation to the reported failure mode: "review of product labeling: ¿ a tfe coated wire guide must be used with ultrathane catheters.¿ activate the hydrophilic coating, if present, by wetting the catheter with sterile water or saline.For best results, keep catheter surface wet during placement.¿ catheters should be irrigated on a routine basis to ensure function.How supplied upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr, ifu and the 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, no returned device, and the results of the investigation, it was determined the cause of this event is related to component failure without evidence of a manufacturing 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: 15383563
• MDR Text Key: 306594772
• Report Number: 1820334-2022-01470
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002123854
• UDI-Public: (01)00827002123854(17)230710(10)13296583
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/17/2023

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: 07/10/2023
• Device Model Number: N/A
• Device Lot Number: 13296583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 09/15/2022; 10/07/2022; 02/08/2023
• Supplement Dates FDA Received: 09/20/2022; 10/07/2022; 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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