MAUDE Adverse Event Report: COOK INC ULTRATHANE 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
The customer reported that, after the ultrathane mac-loc locking loop multipurpose drainage catheter was placed in the patient to drain an abdominal abscess, a leak was discovered in between the hub and the catheter sections of the device.However, the customer confirmed that no separation of the hub occurred.The complaint device was removed, and a new product was opened and used to complete the procedure.No patient adverse events were reported.The device is reportedly unavailable for return and evaluation.
Additional Manufacturer Narrative
Additional information/corrected data: b5- after further review of the record, it was determined that it should be clarified the procedure being performed at the time of event was a percutaneous transhepatic cholangiography drainage and the patient demographics are not available (a3, & a4 updated).It was also noted that only a guidewire was used during catheter removal (d11 updated).Investigation - evaluation.A review of the complaint history, device history record, drawings, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.No device was returned therefore a returned device investigation could not be completed.However, 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 for lot 8513202 revealed no relevant non-conformances.Additionally, a review was performed on subassemblies for catheter tubing, mac-loc assembly, and cap which revealed no relevant non-conformances.A complaint lot search of the manufacturer's database for lot 8513202 revealed no other related complaints.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.The appropriate personnel have been notified, and this failure mode will continue to be trended.Per quality engineering risk assessment, there is no further actions required at this time.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 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: 7396527
• Report Number: 1820334-2018-00857
• Device Sequence Number: 1094285
• Product Code: GBO
• UDI-Device Identifier: 00827002095038
• UDI-Public: (01)00827002095038(17)210116(10)8513202
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 01/16/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-6S-CLM-RH
• Device Lot Number: 8513202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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: WIRE GUIDE