MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Catalog Number	ULT8.5-38-25-P-5S-CLDM-WF-HC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #: exempt.(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
It was reported that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was placed into the abdomen of a patient during a drainage procedure.It was noted that the catheter was unable to drain.The defective device was removed and another like device was opened to complete the procedure.No adverse effects to the patient have been reported.
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, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.One locked 8.5fr mac-loc catheter was returned in a used condition for evaluation.Biological matter was present on the device, particularly at the hub.No additional surface damage was noted on the device; however, the distal end of the tubing was discolored from use.A leak test was conducted and confirmed the presence of a leak between that catheter tubing and connector cap.There was found to be no occlusion within the lumen, as water was able to flow freely from the end of the tubing after hemostat removal.Tug and twist tests revealed that the proximal assembly was secure.Upon removal of the connector cap, the suture string was found slightly wound in the threads.The flare appeared lopsided with a 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.There is no evidence to suggest the existence of issues or gaps that could contribute to the release of nonconforming product related to the reported failure mode.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 found no relevant nonconformances that could have contributed to the reported failure mode in the main and subassembly lots.One nonconformance was found for a similar device for no visible suture at the connector cap in which the one affected device was scrapped.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.Per the quality engineering risk assessment no further action is required.The appropriate personnel have been notified and 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: 7881950
• Report Number: 1820334-2018-02716
• Device Sequence Number: 11221883
• Product Code: GBO
• UDI-Device Identifier: 00827002137660
• UDI-Public: (01)00827002137660(17)210320(10)8679551
• Combination Product (Y/N): N
• 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): 12/03/2018

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: 03/20/2021
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-WF-HC
• Device Lot Number: 8679551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 09/17/2018
• 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