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 Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

Customer street: (b)(6).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 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 or that a death or serious injury occurred; nor is it admission 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

It was reported that the flexible stiffening cannula of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was difficult to advance.During the placement procedure in the biliary tract of a liver transplant patient, the wire guide was unable to advance through the flexible stiffener.A new like-device was obtained to successfully completed the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Upon investigation of the returned device, it was noted that the flexible stiffener was lodged inside the catheter.Further investigation revealed elongation of the flexible stiffener, thus prompting this report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation: cook china received a complaint from jihao pan, a representative at the sinopharm group medical-tech co.Ltd, located in the city of shanghai cn, regarding an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-5s-cldm-hc; lot #:14792483).During the placement procedure in the biliary tract of a liver transplant patient, the wire guide was unable to advance through the flexible stiffener.A new like-device was obtained to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.An examination of the returned device showed evidence of difficult removal of the flexible stiffener from the catheter.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, functional test, and dimensional verification of the returned device, were conducted during the investigation.The ult8.5-38-25-p-5s-cldm-hc, ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was returned in an opened, altered, and damaged condition.The catheter was returned with the supplied flexible stiffener partially inserted, with approximately 6.5 cm extending out from the mac-loc adaptor.The flexible stiffener was missing the hub.After manipulating the distal tip of the catheter, the blue flexible stiffener was able to be removed from the catheter.Material elongation was noted, measuring from the hub end at approximately 14.5 cm and having a length measurement of approximately 29.2 cm.Kinks where also noted in the shaft of the stiffener at 32 cm, 33 cm and 39 cm, when measuring from hub end.The suture string was intact, and when pulled, the specified catheter loop formation was able to be formed.A dissection of the catheter was performed, confirming relevant dimensions such as catheter inner diameter and flexible stiffener outer diameter to be within specification.Additionally, a document-based investigation evaluation was performed.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.A review of the device history record (dhr) for 14792483 and all related subassembly lots confirmed there were no relevant recorded non-conformances.To date, a further search of our database records discovered no additional complaints received from the provided lot.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints from the field.Cook medical has concluded there is no evidence that non-conforming product exists in house or in the field, and that the device was manufactured to current specifications.Cook also reviewed the product labeling.The product ifu, [t_multi2_rev1] ¿multipurpose drainage catheter,¿ states: "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.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook medical 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: 16627556
• MDR Text Key: 312415180
• Report Number: 1820334-2023-00333
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)250614(10)14792483
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

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 Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 14792483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 06/04/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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
• Treatment: UNKNOWN WIRE GUIDE
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 70 KG