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 Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 03/18/2021

Event Type  Injury  

Event Description

It was reported that a patient experienced insufficient drainage and pain related to an ultrathane mac-loc locking loop multipurpose drainage catheter.The device was required for a study procedure ((b)(4)) to treat pleural effusion.Dilation was performed prior to catheter placement, then the device was successfully placed via ultrasound guidance.Drainage was established; however, complete fluid evacuation was not achieved and the pleural effusion increased in size.The patient also experienced catheter-related pain.As a result, the device was removed two days after placement related to ongoing pain at catheter site.No other adverse events were reported due to this occurrence.

Manufacturer Narrative

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.

Manufacturer Narrative

Investigation ¿ evaluation on 23may2022, cri via (b)(6) medical center (usa) reported to cook that a patient experienced insufficient drainage and pain related to an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: (b)(4); lot#: 13619199).The device was required for a study procedure (mdr-1919) to treat pleural effusion.Dilation was performed prior to catheter placement, then the device was successfully placed via ultrasound guidance.Drainage was established; however, complete fluid evacuation was not achieved, and the pleural effusion increased in size.The patient also experienced catheter-related pain.As a result, the device was removed two days after placement related to ongoing pain at catheter site.No other adverse events were reported due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures of the complaint 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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot 13619199 revealed no related non-conformances, and there are no other lot-related complaints that have been received from the field.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 reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi2_rev1, multipurpose drainage catheter] with the device contains the following in relation to the reported failure mode: "how supplied: upon removal from package, inspect the product to ensure no damage has occurred.Intended use: multipurpose drainage catheters are intended for percutaneous drainage applications (e.G.Nephrostomy, biliary and abscess), either by direct stick or seldinger access technique.Warnings: if a catheter has become malposition or if drainage ceases, the catheter should be promptly exchanged or removed." based on the information provided, no returned device, and the results of the investigation, cook concluded the root cause cannot be traced to device.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 ; 8128294891
• MDR Report Key: 14578688
• MDR Text Key: 293302092
• Report Number: 1820334-2022-00993
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)231209(10)13619199
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 13619199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 67 KG