MAUDE Adverse Event Report: COOK INC ULTRATHANE LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that an ultrathane locking loop multipurpose drainage catheter (rpn and lot number unknown at this time) was discovered during a routine exchange to have a "structural issue".The male patient has had a left nephrostomy since 2014 that requires a routine device exchange every 2-3 months.This catheter was initially placed on (b)(6) 2023.Exact removal date is unknown.A customer provided photo shows ballooning of the catheter wall.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

E3- occupation: clinical supply chain manager.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 patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: on 08jul2023, cook medical inc received a complaint from the (b)(6) located in the city of brooklyn, ny.Following a routine exchange using an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-5s-cldm-hc, lot: unknown), it was discovered the catheter had a significant structural issue (ballooning) proximal to the curve.It is currently unknown if the patient experienced any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, instruction for use (ifu), manufacturing instructions and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; 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 currently in place to prevent the release of non-conforming product related to the reported failure mode.A review of the device history record (dhr) could not be completed due to the lack of lot information from the facility.An expanded sales search to the customer was unable to identify the complaint lot.Cook also reviewed product labeling.The current instructions for use [ifu__multi2_rev1] state the following: precautions patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.How supplied upon removal from package, inspect the product to ensure no damage has occurred.Evidence gathered upon a review of the dmr and ifu 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 product, and the results of our investigation, it was concluded that a component failure, without any design or manufacturing issue contributed to the reported event.It is feasible to suggest that during the discharge of fluid the drainage catheter became occluded, resulting in the ballooning of the material.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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.

• Brand Name: ULTRATHANE 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: 17108379
• MDR Text Key: 317443062
• Report Number: 1820334-2023-00716
• 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
• Report Date: 09/19/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/19/2023
• 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
• Patient Sex: Male