MAUDE Adverse Event Report: COOK INC ULTRATHANE 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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported the flexible stiffener of unknown ultrathane mac-loc locking loop multipurpose drainage catheters was difficult to advance and remove.A physician, who has been exclusively using cook drains over the years, had difficulty advancing and removing the flexible stiffener.The physician found a "work around" by flushing the inside and outside of the dilator and drain, straightening the drain out prior to inserting the dilator, and pulling the wire back before taking the inner dilator out.Due to immediately finding this "work around," the physician delayed reporting the incident to cook.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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

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 was received 28feb2023.It was reported that this is a general complaint from the physician.There is no specific patient demographic information or device information that can be provided.No adverse effects have been reported.

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.On 16feb2023, cook medical received a complaint from the (b)(6) facility, located in the city of (b)(6).They report on multiple occasions difficulty was encountered when advancing and removing the supplied flexible stiffener from the catheter.No specific patient demographics and/or product information could be provided other than being of a ultrathane mac-loc locking loop multipurpose drainage catheter.The patient outcomes are unknown.Reviews of the instructions for use (ifu), drawings, manufacturing instructions, quality control procedures, and specifications of the device were 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.Cook reviewed the device master record (dmr) for the catheter and flexible stiffener.The rpn of the complaint device was not provided.Cook medical performed an expanded sales over three years prior to the date cook was informed (16feb2019 ¿ 16feb2023).Based on the information collected, cook assumes the rpn is of an ult8.5-38-25-p-6s-clm-rh, due to the overall sales.Cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.A review of the sales records could not sufficiently narrow down the lot number.Cook 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.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 and ifu suggests that the devices were not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no returned device, and the results of the investigation, cook determined a definitive cause of failure could not be established.A capa was previously opened for this product failure, and corrective actions were implemented related to supplier manufacturing of the catheter tubing.Because the lot number was not provided, it is unknown whether the complaint lot was manufactured prior to or after these corrections.Based on the provided information, it is possible that supplier manufacturing issue contributed to this failure.However, this cannot be confirmed.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.

• Brand Name: ULTRATHANE 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: 16448472
• MDR Text Key: 310435615
• Report Number: 1820334-2023-00192
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 02/28/2023; 06/07/2023
• Supplement Dates FDA Received: 03/02/2023; 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1