BEUDAMED
    FDA Adverse Event Other Summary report: N

    SKATER CATHETER

    MDR report key: 2366291 · Received December 6, 2011

    Report

    Report Number
    1036710-2011-00015
    Event Type
    Other
    Date Received
    December 6, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 15, 2011
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    GBQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THE SUTURE BECAME DETACHED AND WAS LEFT IN THE PT. NO SAMPLE IS AVAILABLE FOR REVIEW. THE PART NUMBER AND LOT NUMBER FOR THE CATHETER USED WAS NOT KNOWN BY THE REPORTER. THE REPORTER STATES THIS IS A COMMON OCCURRENCE ON THEIR END; HOWEVER, THIS TIME BOTH ENDS OF THE SUTURE WERE DROPPED AND THE SUTURE WAS LOST INSIDE THE PT. THE IFU FOR THE PRODUCT STATES TO CHECK THAT BOTH THREADS ARE LOOSE AND CUT ONE THREAD IN ORDER TO LOOSEN THE PIGTAIL. ONLY ONE END OF THE SUTURE SHOULD BE CUT SO THAT THE TAB IS STILL ATTACHED AND USED AS AN ANCHOR. PER F/U WITH THE CUSTOMER THE SUTURE HAS BEEN REMOVED FROM THE PT. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    MD STATES THAT UPON REMOVAL OF A SKATER ALL PURPOSE CATHETER, THE NYLON SUTURE BECAME DETACHED AND WAS LEFT IN THE PT. SURGICAL PROCEDURE REQUIRED TO REMOVE THE SUTURE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKATER CATHETER ALL PURPOSE DRAINAGE CATHETER GBQ ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention