MAUDE Adverse Event Report: COOK INC ULTRATHANE MULTIPURPOSE DRAINAGE SET; 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	10/11/2018
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 mac-loc locking loop multipurpose drainage catheter was placed in the patient's bile duct for a percutaneous transhepatic cholangio-drainage procedure.After placement, aspiration difficulty was encountered due to air entering the catheter.The device was replaced with a like catheter 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
Investigation - evaluation.A review of the complaint history, device history record, documentation of the device, as well as repeat investigation involving a similar affected product with the same failure mode was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.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 revealed no relevant nonconformances that could have contributed to this failure mode.It should be noted that there were no other complaints reported for lot 9084307 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 a similar product evaluation 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.

• Brand Name: ULTRATHANE MULTIPURPOSE DRAINAGE SET
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8000044
• Report Number: 1820334-2018-03169
• Device Sequence Number: 202892
• Product Code: GBO
• UDI-Device Identifier: 00827002300279
• UDI-Public: (01)00827002300279(17)210904(10)9084307
• Combination Product (Y/N): N
• 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): 12/28/2018

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: 09/04/2021
• Device Model Number: N/A
• Device Catalogue Number: CLDM-10.2-MH
• Device Lot Number: 9084307
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 10/24/2018
• 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