BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOCATH-T SUBCLAVIAN 14G 5-1/2IN

    MDR report key: 3810847 · Received April 1, 2014

    Report

    Report Number
    3005515211-2014-00005
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    June 12, 2013
    Report Date
    March 5, 2014
    Manufacturer
    AMSINO MEDICAL CO., LTD. (
    Product Code
    FOZ
    PMA / PMN Number
    PREAMEN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED ONE POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 01205KY. SEALED DEVICES FROM LOT#01205KY WERE EVALUATED. THE DEVICES PASSED TESTING. DURING THE INVESTIGATION, THE CAUSE OF THE BROKEN CATHETER TIP WAS DUE TO PRODUCT MISUSE BY THE END USER WHO DID NOT USE THE DEVICE ACCORDING TO THE PRODUCT LABEL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BREAKAGE OF THE TIP OF THE DEVICE. IT WAS REPORTED THAT THE CATHETER WAS BEING USED FOR LASER ABLATION OF THE PROSTATE PER RESEARCH PROTOCOL. THE CUSTOMER CONTACT REPORTED THAT PRIOR TO INSERTION OF THE DEVICE, THE NEEDLE INSIDE THE DEVICE WAS REMOVED AND REPLACED WITH AN MRI (MAGNETIC RESONANCE IMAGING) COMPATIBLE TITANIUM NEEDLE. THE CATHETER WITH THE REPLACEMENT NEEDLE WAS THEN INSERTED INTO THE PERINEUM TOWARDS THE PROSTATE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE POSITIONING OF THE DEVICE WAS UNSATISFACTORY AND THE DEVICE WAS PULLED BACK. NO SPECIFIC DETAILS WERE PROVIDED. AT THIS TIME, THE PHYSICIAN NOTED THAT A COUPLE CENTIMETERS OF THE DISTAL PORTION OF THE CATHETER WAS MISSING AND REMAINED INSIDE THE PT. NO FURTHER ABLATION WAS PERFORMED. ON AN UNSPECIFIED DATE, THE PT UNDERWENT A PROCEDURE FOR SUBCUTANEOUS FAT REMOVAL TO REMOVE THE FRAGMENT. DURING A VISUAL EXAMINATION OF THE CATHETER AT THE USER FACILITY, THE CUSTOMER CONTACT REPORTED THAT THE TIP OF THE CATHETER HAD A CLEAN BUT IRREGULAR CUT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196072 ABBOCATH-T SUBCLAVIAN 14G 5-1/2IN 80FOZ FOZ AMSINO MEDICAL CO., LTD. ( NA PLOTSKY

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT Required Intervention TITANIUM TROCHAR, MFR VISUALASE,| PRODUCT# TTSH-165-14, LOT# 13041602