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 Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an ultrathane mac-loc locking loop biliary drainage catheter kinked and leaked at the hub during an unspecified procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event and has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 - annex a.Investigation ¿ evaluation: on 29jun2023, cook medical received a complaint from the queens medical ctr west oahu, located in the city of ewa beach hi.They report after the placement of the ult10.2-38-25-p-5s-cldm-hc, ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter, the radiologist was injecting contrast to confirm placement when they noticed leakage between the cap and mac-loc.The technologist assisting with the procedure stated that there was no kink or bend in the catheter.The radiologist was able to replace the catheter without any issues.Reviews of documentation including the complaint history, device history record (dhr), quality control, specifications, and instructions for use (ifu) 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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The lot number was not provided; therefore, cook medical performed an expanded sales search from 29jun2020 up to 29jun2023 for the reported device.The search could not identify the complaint lot.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu [ t_multi2 rev1, multipurpose drainage catheter] supplied with the device states the following in consideration of the reported failure mode: ¿ 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.Based on the available information, no product returned, and the results of the investigation, cook determined the cause of this event is component failure.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 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.

Event Description

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

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

In additional information received on 13jul2023, it was reported that the radiologist was injecting contrast to confirm placement when they noticed the leakage.The technologist assisting with the procedure stated that there was no kink or bend in the catheter.The radiologist was able to replace the catheter without any issues.A photo of the complaint device provided by the facility indicated that leakage occurred between the mac-loc hub and cap.

• 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: 17283172
• MDR Text Key: 318682153
• Report Number: 1820334-2023-00882
• Device Sequence Number: 1
• Product Code: GBO
• 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: 09/18/2023

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: ULT10.2-38-25-P-5S-CLDM-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 07/13/2023; 08/23/2023
• Supplement Dates FDA Received: 07/18/2023; 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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