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 No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Occupation: clinical products and contracts manager.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.

Event Description

It was reported that the operator experienced difficulty removing an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter from an unknown patient.The date the device was inserted into the patient is unknown.The difficulty was experienced during removal on (b)(6) 2020.No adverse effects were reported.

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 mater public hospital (australia) informed cook that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was difficult to remove from a patient.The catheter was implanted on (b)(6) 2020 and scheduled for removal on (b)(6) 2020.The patient was being treated for ascites.The user unlocked the drain and withdrew the device, but the suture would not release.The catheter was cut and the device was removed.The patient did not require additional procedures.A review of the complaint history, device history record, instructions for use (ifu), and quality control of 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.There are appropriate controls in place to detect this failure prior to distribution.The risks of this device 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: "precautions -manipulation of products requires ultrasound, fluoroscopy, or other imaging guidance.Unlocking catheter loop for mac-loc® locking loop mechanism: a.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.B.Pry upward until the locking cam lever is free.Note: for catheter exchange, advance the distal end of a wire guide into the locked loop configuration of the catheter before unlocking the mac-loc assembly.Release the mac-loc as described above.Advance the wire guide through the catheter end hole.Catheter exchange can now be performed." 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 dhr for the complaint lot and related subassembly lots did not have related nonconformances.There is one additional complaint on this lot from the same user facility.The additional complaint, reported under medwatch report#:1820334-2020-01766, reports the same failure during a different event.The user had difficult removing the drain and needed to administer local anesthetic for removal.The device was not returned for evaluation.Although there is an additional complaint on this lot, there are no related nonconformance and the complaint devices were not returned for evaluation.There is no evidence of nonconforming material in house or in the field.The device was not returned for evaluation, so cook did not confirm that it was manufactured out of specification.It is possible that the mac-loc mechanism was not fully unlocked, but this was not confirmed.Based on the information provided, no returned product, and the results of the investigation, it was concluded component failure without design or manufacturing deficiency contributed to this event.The appropriate personnel have been notified.Per the quality engineering 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

Additional information provided 08oct2020: the device was placed 18sep2020 and was in place for 8 days before removal.The device was being used for an ascitic tap.When the lever was pulled, the suture did not release and the device had to be cut in order to remove it.No additional procedures were required to remove the device.

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.

• 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: 10638579
• MDR Text Key: 210226462
• Report Number: 1820334-2020-01813
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)230624(10)13264150
• 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,Followup
• Report Date: 11/18/2020

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: 06/24/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 13264150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 11/09/2020
• Supplement Dates FDA Received: 10/19/2020; 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C-CTU14.0-30-ST; SDN-18-7.0; TSF-35-80