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 Device Embedded In Tissue or Plaque (3165)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: clinical facilitator, clinical education.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 an unknown patient underwent a procedure to remove an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter that was being used to drain ascites.The nurse reportedly experienced significant resistance trying to remove the drain which cased the patient significant pain.A physician cut the catheter in order to remove it, however, the suture remained in the patient after the catheter was removed.The doctor was able to remove the string manually.No other adverse effects were reported.

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

Additional information received 25nov2020 stated that the initial attempt came with a lot of resistance.Pain relief was administered and the drain was left for 30 mins.The second attempt experienced the same resistance.The device was in place for one day and no encrustation or visible damage to the drain was noted.The suture string was trimmed and not wrapped around the mac loc during placement.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation (b)(6) hospital in australia informed cook that on (b)(6) 2020, a user had difficulty removing an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter after use.The catheter was placed the previous day as an ascites drain.Upon device removal, the user was unable to withdraw the drain after unlocking the mac-loc.This created resistance during withdrawal and the patient experienced pain.The user administered local anesthetic and cut the catheter to remove it.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control of the device was 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 appropriate controls in place to detect this failure prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot and the relevant mac-loc subassembly lot revealed no related nonconformances.A database search did not identify any other events associated with the reported device lot.Based on this 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 the field.Cook also reviewed product labeling.The device is supplied with instructions for use, which states the following in relation 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." based on the information provided, no product returned, and the results of our investigation, the cause for this event has been traced to component failure without design or manufacturing deficiency.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 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: 10824078
• MDR Text Key: 217957021
• Report Number: 1820334-2020-02069
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)230730(10)13336635
• 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: 02/22/2021

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: 07/30/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 13336635
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 01/28/2021
• Supplement Dates FDA Received: 12/13/2020; 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other