MAUDE Adverse Event Report: COOK, INC. ULTRATHANE DAWSON MUELLER MAC LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

Catalog Number ULT7.0-35-25-P-5S-CLDM-WF-HC

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

September 2013 a pt underwent a successful ptcd procedure; however, approx a week after the placement, deviation of it from the placed position was confirmed.When this event was confirmed, the mac-lock of the catheter was firmly locked.If mac-lock functioned as intended, the catheter would not deviate.No info provided regarding pt outcome.

Manufacturer Narrative

The device was not returned for investigation.Our investigation process included the following reviews: complaint history, ifu, qc and trends.The description of event stated, "a week after the placement, deviation of it from the placed position was confirmed.When this event was confirmed, the mac-lock of the catheter was firmly locked.If mac-lock functioned as intended, the catheter would not deviate.Considering above, i (user) am not sure, but i think there is a possibility that the suture of it was separated somehow and this event occurred." based on the description, it is likely that the suture broke while in the pt causing the tip of the catheter to uncurl and move from its original position.Per qc specification, ac personnel confirms the integrity of the device.The device is shipped with ifu, which lists the appropriate warnings, precautions and instructions for use.Due to the limited info and without the device for investigation, a definitive root cause cannot be determined.We have notified appropriate personnel and will continue to monitor for similar complaints.Insufficient risk per quality engineering risk assessment.

• Brand Name: ULTRATHANE DAWSON MUELLER MAC LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN
• Manufacturer Contact: rita harden, dir ; p.o. box 489; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4226683
• MDR Text Key: 4972719
• Report Number: 1820334-2014-00511
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2014,10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-WF-HC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1