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
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported an unknown patient required placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for a percutaneous transhepatic cholangiography procedure.When the patient was transferred to patient's bedroom after the procedure, "leakage of the bile" was confirmed from the edge of the hub.The catheter was replaced with a new, similar device.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Investigation ¿ evaluation.(b)(6) hospital (japan) informed cook that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked from the hub.The device was placed during ptcd procedure in the patients abdomen.The patient was transported to their room after the procedure, and staff noticed the device was leaking bile from the hub.The device was removed and replaced without adverse effects to the patient.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The customer did not return the complaint device for evaluation.Therefore, no visual inspection of the device was performed.Additionally, a document-based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) for the lot revealed no related nonconformances.A complaint database search was completed.There were no additional complaints on this lot from the field.There is no evidence of nonconforming material from this lot in house or in the field.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.Based on the information provided, no returned product, and results of the investigation, it was concluded the cause for this event is component failure without design or manufacturing deficiency.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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 or Problem 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
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9841710
• Report Number: 1820334-2020-00626
• Device Sequence Number: 727135
• Product Code: GBO
• UDI-Device Identifier: 00827002137660
• UDI-Public: (01)00827002137660(17)230115(10)10267829
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-WF-HC
• Device Lot Number: 10267829
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention