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 Leak/Splash (1354)

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

Event Date 11/19/2020

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

As reported, an unknown patient required the placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for an unknown drainage procedure.The operator reported when they "tried to inject through the hub of the catheter" leaking was found between the hub and the catheter.This occurred with two devices of the same lot.No adverse effects were reported for this event.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, 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.

Event Description

Additional information received 02dec2020 clarified that the devices made patient contact and that the leak occurred during use.

Manufacturer Narrative

Investigation: evaluation: seoul nat.Univ.Bundang hosp.(republic of korea) informed cook that on (b)(6) 2020, two ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheters leaked during a percutaneous biliary drainage procedure.The user noticed hub leakage when they tried to inject through the catheter hubs.The patient did not experience adverse effects.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control of the device was 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.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 the design history file (dhf) showed that this device is both safe and effective for its intended use.The device history record for the complaint lot was reviewed to check for related nonconformances and additional complaints.The complaint lot had one related nonconformance for four devices failing the proximal fitting gap gauge.All devices were scrapped.This product is 100% inspected to ensure the proximal fittings are correct.There are no additional complaints on this lot.Cook also reviewed product labeling.The ifu supplied with mac-loc drainage catheters instructs to inspect the product prior to use to ensure no damage has occurred.Based on the device master record review, device history record review, and device failure analysis, there is no evidence the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.There is no evidence of manufacturing deficiency.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause for this event has been traced to a component failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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
• MDR Report Key: 10920099
• MDR Text Key: 218981669
• Report Number: 1820334-2020-02195
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)230818(10)13373892
• 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,Followup
• Report Date: 03/31/2021

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: 08/18/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 13373892
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 03/22/2021
• Supplement Dates FDA Received: 12/13/2020; 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1