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U.S. Department of Health and Human Services

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

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COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2023
Event Type  malfunction  
Manufacturer Narrative
D4 - rpn: ult7.0-35-25-p-5s-cldm-tong-050399.G4 - 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.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
It was reported that the metal stiffening cannula of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was difficult to remove during an unknown procedure on an unknown patient.The stiffener was inserted into the catheter without difficulty and locked at the hub.When the device was checked again prior to insertion into the patient, it was noted that the hub was tight, and the stiffener was difficult to remove from the catheter.It was decided to discontinue use of the product, and a new like-device was opened to complete the procedure.Following the procedure, the user reported that the stiffener was able to be removed by applying "a lot of force." no damage was found on the package prior to use.The device was stored horizontally.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
 
Manufacturer Narrative
Investigation ¿ evaluation: it was reported that the metal stiffening cannula of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was difficult to remove.The stiffener was inserted into the catheter without difficulty and locked at the hub.When the device was checked again prior to insertion into the patient, it was noted that the hub was tight, and the stiffener was difficult to remove from the catheter.It was decided to discontinue use of the product, and a new like-device was opened to complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications, and instructions for use (ifu), as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used device was returned to cook for evaluation.The device was received with the stiffening cannula fully inserted into the catheter.The stiffening cannula was confirmed to be stuck within the catheter.The distal tip of the catheter was manipulated, which released the stiffener.No damage was present on the catheter or stiffening cannula.Reinsertion and removal of the stiffening cannula into and out the catheter were successful.Both the inner diameter of the catheter and outer diameter of the stiffening cannula were confirmed to be within specification.Additionally, 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 dhrs for the reported complaint device lot and the related subassembly lots revealed no relevant non-conformances.A database search did not identify any other events associated with the reported device lot.Cook also reviewed product labeling.The product ifu, [t_multi2} ¿multipurpose drainage catheter,¿ provides the following information to the user related to the reported failure mode: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ instructions for use: ¿under fluoroscopic control, perform standard techniques for placement of percutaneous draining catheters, either by seldinger access or trocar access.Once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to for its configuration.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr 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, inspection of the returned device, and the results of the investigation, the cause of this event was traced to component failure without a manufacturing or design deficiency.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.
 
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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
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key17590997
MDR Text Key321629830
Report Number1820334-2023-01121
Device Sequence Number1
Product Code GBO
UDI-Device Identifier00827002128767
UDI-Public(01)00827002128767(17)250719(10)14847953
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/28/2023
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 NumberN/A
Device Lot Number14847953
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/16/2023
Initial Date FDA Received08/21/2023
Supplement Dates Manufacturer Received12/03/2023
Supplement Dates FDA Received12/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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