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 Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 04/05/2022

Event Type  malfunction  

Event Description

It was reported a patient required an ultrathane mac-loc locking loop multipurpose drainage catheter.Upon placement of the device, it was noted the hub was cracked and leaking.The device was replaced with another device of the same lot, and the same failure was observed.A third catheter was placed successfully without leaking.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: on 06apr2022, a representative at the osu medical center, located in the city of columbus oh, reported to cook medical inc.About ultrathane mac-loc locking loop multipurpose drainage catheters (rpn: ult10.2-38-25-p-6s-clm-rh; lot #: 14462317) leaking at the hub.Upon placement of the first drainage catheter, the hub of the drainage catheter was observed to be cracked and leaking.The device was removed and replaced with a second drainage catheter of the same lot number and the same failure was observed.A third drainage catheter was used to successfully 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), instructions for use (ifu), and quality control procedures, as well as a a visual inspection of the returned device, were conducted during the investigation.Two used drainage catheters were returned to cook for evaluation.A visual examination of both devices confirmed a crack to be present within the mac-loc body cavity.Upon removing the connecting cap from the mac-loc, it was confirmed the cracks were isolated within the mac-loc cavity and did not extend into the threads of the mac-loc adaptor.There is no evidence to suggest that product was not manufactured to current specifications.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 dhrs for the reported complaint device lot 14462317 and the related subassembly lot sa14434503 revealed one related non-conformance for "mac-loc damage" in which one device was scrapped prior to further processing of the order.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot.Cook reviewed the product labeling.The instructions for use (ifu) [ t_multi2_rev1, multipurpose drainage catheter] packaged with the device contains the following in relation to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr, ifu, and dhrs 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 root cause was concluded to be component failure without any design or manufacturing issue.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 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: 14188047
• MDR Text Key: 289896502
• Report Number: 1820334-2022-00638
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)250110(10)14462317
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• 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: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 14462317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• 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: BOSTON ACCUSTICK