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 Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: clinical products and contracts manager.Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a male patient required removal of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for an ascitic tap pigtail drain removal procedure.During the procedure, it was noted the drain became "lodged" and resistance was felt when pulled.This caused the patient to tense up and "clench into his stomach," due to the pain.The operator cut the drain line and removed the drain without any resistance.The drainage tip and wire were inspected upon removed and were confirmed to be intact and undamaged.Pain relief was administered.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation.Mater hospital brisbane, in australia, informed cook of an incident involving an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter [rpn: ult8.5-38-25-p-5s-cldm-hc from lot# 13390058].The complainant reported the drain was difficult to remove.The device was placed on (b)(6) 2020 and was removed on (b)(6) 2020.Upon removal, the user noted resistance while withdrawing the drain, and the patient reported pain.The user cut the catheter and successfully removed the device.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control of the device, as well as a visual inspection of the returned device, were conducted during the investigation.The affected device was returned to cook for investigation.The physical/visual examination of the returned device showed one used ult8.5fr received with bio-matter present.The catheter was received cut in two sections.One section consists of the mac-loc and 1.2cm of tubing and the other is a 28cm section of catheter tubing.The string is broken with 49cm of string separated.Additionally, a document based investigation evaluation was performed.A device master record (dmr) review was performed and quality control procedures associated with the complaint were identified.Cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.The device is shipped with instruction for use (ifu), which provides the following information to the user related to the reported failure mode: unlocking catheter loop ¿while stabilizing the mac-loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the mac-loc release notch.Pry upward until the locking cam lever is free.¿ a review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The device history record (dhr) review on lot# 13390058 and related subassembly lots recorded potential related non-conformances for rough sideports, which were scrapped.The device undergoes 100% inspections for this failure.A database search revealed no additional complaints for the complaint lot from the field.From the dmr review, dhr review and ifu review, there is no evidence to indicate the device was manufactured out of specification, or that there are non-conforming devices in house or in the field.Based on the information provided, the examination of returned product and the results of the investigation, cook has concluded that the main cause of the failure is due to component failure unrelated to manufacturing or design deficiencies.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook 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.

Event Description

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

• 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
• MDR Report Key: 11047820
• MDR Text Key: 222780181
• Report Number: 1820334-2020-02349
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)230826(10)13390058
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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: 08/26/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 13390058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SDN-18-7.0 COOK NEEDLE; TSF-35-80 COOK WIRE GUIDE; SDN-18-7.0 COOK NEEDLE; TSF-35-80 COOK WIRE GUIDE
• Patient Age: 50 YR