MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Catalog Number	ULT10.2-38-40-P-32S-CLB-RH
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #: not exempt, pre-amandment.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 an ultrathane mac-loc locking loop biliary drainage catheter was placed into the biliary tract of a patient during a drainage procedure.Not long after device placement, it was discovered that air was leaking from the hub.The physician opened another like device and completed the procedure successfully.
Additional Manufacturer Narrative
Additional information: investigation - evaluation.A review of the complaint history, device history record, documentation, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.One locked 10.2fr mac-loc catheter was returned in used condition for evaluation.The device was returned with the metal cannula fully inserted.Upon removal of the cannula, no resistance was experienced.Biological matter was present on the device with no additional surface damage noted.A leak test was conducted and confirmed the presence of a leak between that catheter tubing and connector cap.Tug and twist tests revealed that the proximal assembly was secure, however, the tubing was noted to be able to freely rotate within the cap.This indicates that the catheter flare was not fully compressed, although it is possible that the tubing became dislodged during use.Upon removal of the connector cap, the suture string was found to be heavily wound in the threads.The flare appeared lopsided with 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.The instructions for use (ifu) advise the user to inspect the product prior to use to ensure that no damage has occurred.A review of the device history record shows no nonconforming events which could contribute to this failure mode in the device main and subassembly lots.One relevant nonconformance was found in a similar device lot for a damaged mac-loc and cap, in which the seven devices affected were replaced.It should be noted that there were no other complaints reported for this or similar device lots.Based on the information provided, examination of the returned product and the results of our investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.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 new event description information to report at this time.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Common Device Name: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7877536
• Report Number: 1820334-2018-02680
• Device Sequence Number: 2061697
• Product Code: GCA
• UDI-Device Identifier: 00827002094987
• UDI-Public: (01)00827002094987(17)210518(10)8894890
• 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): 12/03/2018

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: 05/18/2021
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Device Lot Number: 8894890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO WIRE GUIDE