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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was placed in the patient's bile duct for a percutaneous transhepatic cholangio-drainage (ptcd) procedure.Angiography was used to confirm catheter placement.When aspiration was performed to verify device function, nothing was aspirated.The physician then flushed the catheter and discovered leakage around the hub.The device was replaced and the procedure was completed successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Product received on: 30oct2018.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 unlocked 10.2fr mac-loc catheter was returned for evaluation in used condition.Biological matter was present on the device with no additional surface damage noted.A leak test was conducted and was unable to confirm the presence of a leak in the device.Tug and twist tests revealed that the proximal assembly was secure.Upon removal of the connector cap, the suture string was found normal in the threads.The flare appeared slightly frayed and had multiple lips, 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.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record for lot 9085707 found no relevant nonconformances that could be associated with this failure mode.Two nonconformances were found in tubing subassembly lots sa9006210 and sa9006211 for tubing obstruction, in which all affected devices were scrapped.It should be noted that there have been no other complaints reported for this or similar device lots.The instructions for use (ifu) advise the user to inspect the product prior to use to ensure that no damage has occurred.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.

• 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: 7980095
• Report Number: 1820334-2018-03146
• Device Sequence Number: 11020332
• Product Code: GBO
• UDI-Device Identifier: 00827002137653
• UDI-Public: (01)00827002137653(17)210810(10)9085707
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 08/10/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-WF-HC
• Device Lot Number: 9085707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1