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 Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.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 placement of an ultrathane mac-loc locking loop multipurpose drainage catheter for a drainage procedure.During the procedure, the stiffener was difficult to remove and got "stuck".Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Event Description

This complaint is being canceled.Additional information was received on 29oct2020 that indicates this event was reported in error.

Manufacturer Narrative

Additional information/correction: this complaint is being canceled.Additional information was received that indicates this event was reported in error.It was originally reported that two devices failed during two events.These two events were reported under medwatch report #1820334-2020-01954 (this report) and medwatch report #1820334-2020-01953.On 29oct2020, additional information was received indicating the two devices, of the same lot, failed during the same procedure on the same patient.Only one report is necessary and all additional information regarding this event will be captured under medwatch report #1820334-2020-01953.No follow up information will be submitted for this report.This complaint will be canceled by the manufacturer.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.

• 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
• MDR Report Key: 10750587
• MDR Text Key: 214373414
• Report Number: 1820334-2020-01954
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097650
• UDI-Public: (01)00827002097650(17)230611(10)13239234
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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: 06/11/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-45-P-6S-CLM-RH
• Device Lot Number: 13239234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1