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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that the stiffening cannula of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was difficult to remove.Using seldinger technique, the device was attempted to be inserted into the bile duct from the abdomen.However, after placing the drainage catheter, the user experienced resistance during attempted removal of the stiffening canula.The device was then completely removed, and the procedure was completed using another manufacturer's catheter.No damage to the packaging was noted prior to use.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D4: device information: catalog #: 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.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported that the stiffening cannula of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was difficult to remove.Using seldinger technique, the device was attempted to be inserted into the bile duct from the abdomen.However, after placing the drainage catheter, the user experienced resistance during attempted removal of the stiffening canula.The device was then completely removed, and the procedure was completed using another manufacturer's catheter.No damage to the packaging was noted prior to use.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection, dimensional verification, and functional test, of the returned device, were conducted during the investigation.The ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was returned in a used condition.The catheter was received with the stiffening cannula fully inserted.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 to the catheter and or stiffening cannula.Reinsertion of the stiffening cannula into the catheter and removal was successful and without difficulty.The inner diameter of the catheter and outer diameter of the stiffening cannula were measured within specification.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also completed a review of the dhr for the reported lot and discovered one possibly relevant recorded non-conformance for "flare inadequate", having a quantity of one.The catheter shaft sub-assembly lots and the disposable stiffening cannula lot had no relevant recorded nonconformances.To date, a further search of our database records for the reported lot number revealed this to be the only reported complaint.Since there is objective evidence the dhr was fully executed, cook medical has concluded there is no evidence that non-conforming product exists in house, in the field and that device was manufactured to current specification.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, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.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 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 Key: 18691357
• MDR Text Key: 335454620
• Report Number: 1820334-2024-00202
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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 Number: N/A
• Device Lot Number: 14865797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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