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	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: terumo wire, sungwon yellow sheath, puncture needle, 018hair wire (cook) etc.(sic).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 or Problem Description
It was reported that during a percutaneous transhepatic biliary drainage (ptbd) procedure, the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter had no air pressure within the catheter and the air was leaking from the catheter hub during in the process of draining.As a result, the catheter was exchanged for another.The patient is reportedly "healthy" following this event.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.  according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
(b)(6).Investigation - evaluation a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.Clinical assessment: a leaking hub could potentially cause infection or poor drainage.At this time, the most probable cause of this event is device failure or device handling related one locked 8.5fr partial catheter was returned for evaluation in damaged condition.The device was comprised of the mac-loc hub, connector cap and approximately 4.5cm of tubing ending with a separation.The separation appeared to be a cut.Biological matter was present on the device and hemostat marks were noted on the connector cap.No additional surface damage was noted on the device.A leak test was conducted and confirmed that presence of a leak between the connector cap and catheter tubing.Tug and twist tests revealed that the proximal assembly was secure, however, the tubing was able to freely rotate within the cap.Upon removal of the connector cap, the suture string was found heavily wound in the threads.The flare appeared slightly lopsided and had a minor lip, but due to the compression of the flare within the cap and the potential for damage upon removal, it cannot be determined if the flare was manufactured to specifications.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.Inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record showed no nonconformances that could have contributed to this failure mode.It should be noted that there were no other complaints reported for lot 8666534.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be established.The appropriate personnel have been notified of this event.Appropriate measures have been taken to address this failure mode.We 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.

• 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: 7912098
• Report Number: 1820334-2018-02991
• Device Sequence Number: 1399904
• Product Code: GBO
• UDI-Device Identifier: 00827002104358
• UDI-Public: (01)00827002104358(17)210314(10)8666534
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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 Expiration Date: 03/14/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Device Lot Number: 8666534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1