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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name- ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reports that a patient underwent placement of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for percutaneous transhepatic biliary drainage (ptbd).The customer reports that "in the process of draining after the ptbd procedure, there was no air pressure within the catheter and the air was leaking from the catheter hub." no further information was provided.Additional event and patient information was requested.A follow-up report will be submitted upon receipt of any additional information.
Additional Manufacturer Narrative
Investigation - evaluation: a review of dimensional verification, functional testing, complaint history, device history record, documentation, drawings, instructions for use (ifu), manufacturing instructions, visual inspection of the returned device, and quality control data was conducted during the investigation.Visual inspection and functional testing of the returned device were performed.The cap was unable to be untwisted from the mac-loc.There were no threads visible between the mac-loc and cap.No cracks were observed in the proximal assembly.The mac-loc was in the locked position.The catheter was returned with the suture cut at the proximal end, such that the suture did not go back through the locking mechanism.The catheter tubing was tugged and twisted with no movement within the proximal assembly.Hemostats were then used to occlude the tubing so that the proximal assembly could be pressurized.A pressure of 7.85 was maintained for approximately 2 min with no drops of water forming or falling form the proximal assembly.A vacuum was then applied to the proximal assembly to test for air leakage.A vacuum was able to be drawn, with no air leakage observed.Dried fluid or biomatter prevented the failure to be duplicated in the lab.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the provided information, inspection of returned product, and the investigation results, a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6811612
• Report Number: 1820334-2017-02361
• Device Sequence Number: 1772763
• Product Code: GBO
• UDI-Device Identifier: 00827002104358
• UDI-Public: (01)00827002104358(17)200418(10)7839338
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1