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 Consequences Or Impact To Patient (2199)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

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 required an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for percutaneous abdominal drainage.After advancing the catheter into the patient, the stylet was "dented" and could not be separated from the catheter.The catheter was removed and replaced to complete the procedure.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 unchanged, unknown, or unavailable.Additional information: b5 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 provided 14feb2021 stated that it was most likely the metal stiffener that experienced the difficulty.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) medical center 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 number 13498832.On (b)(6) 2021, during a procedure, the stylet could not be advanced or removed from the catheter.It was found the stylet was dented and stuck and in the catheter.The device was replaced, and the procedure was completed with no further issues.No unintended section of the device remained inside the patient¿s body, the patient did not require additional procedures due to this occurrence and there have been no adverse effects to the patient due to this occurrence.Further communication confirmed they usually do not use the flexible stiffener and only the metal stiffener.Therefore, the complaint will be investigated on the metal stiffener.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures, were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.Due to this, no dimensional, visual, or functional verifications could be completed.However, a document based investigation evaluation was performed.Adequate risk mitigation activities are in place to capture potential failure modes prior to customer release.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) for lot 13498832 and relevant sub-assembly lots record no related non-conformances.A database search revealed no other complaints have been reported for the device lot.The product ifu 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 device master record, dhr, design history file, and ifu, suggests there is no evidence that the device was manufactured out of specification, or that there are nonconforming devices in house or out in the field.Based on the information provided, no inspection of returned product and the results of the investigation, it was determined the cause of this complaint is traced to a component failure without a manufacturing or design deficiency.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.

• 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: 11338958
• MDR Text Key: 232235072
• Report Number: 1820334-2021-00347
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)231019(10)13498832
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

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: 10/19/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 13498832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 02/14/2021; 01/07/2022
• Supplement Dates FDA Received: 03/03/2021; 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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