BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER INTRODUCER SYSTEM

    MDR report key: 1694418 · Received May 13, 2010

    Report

    Report Number
    1036710-2010-00014
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Date of Event
    February 1, 2010
    Report Date
    April 26, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    DYB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SKATER INTRODUCER SYSTEM USED IN THE PROCEDURE IS NOT AVAILABLE FOR RETURN BY THE CUSTOMER. A REVIEW OF THE DHR COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNK. A REVIEW WAS COMPLETED OF PAST COMPLAINTS RECEIVED FOR THE PRODUCT CODE REPORTED. (B)(4). THE PLATINUM TIP EXTENDS 7.5 +/- 1.0 CM ON THE TIP OF THE GUIDEWIRE. IN THE EVENT REPORTED, 3 MM OF THIS SOLID PLATINUM TIP WAS SHEARED OFF. IN THE PREVIOUS COMPLAINT 3 CM BROKE OFF. A PULL TEST FOR A WELD STRENGTH IS REQUIRED ON A SAMPLING OF EACH LOT DURING THE PRODUCTION OF THE WIRE. (B)(4). THE PULL TEST HAS PULLED ABOVE THE MINIMUM SPECIFICATION ON ALL LOT NUMBERS FOR THE WIRE PRODUCT CODE. IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE DEFECT REPORTED WITHOUT REVIEWING THE CONDITION OF THE WIRE USED IN THE PROCEDURE. IF THE WIRE IS BENT DURING THE PROCEDURE THE BENDING OR FLEXING OF STAINLESS STEEL CORE CAN REDUCE TENSILE STRENGTH. IT IS POSSIBLE THAT AN UNUSUAL EVENT CAUSED THE TIP TO SHEAR OFF AS DESCRIBED.

    Description of Event or Problem · 1

    (B)(6) STATED, HE USED OUR SKATER INTRODUCER SYSTEM DURING INSERTION IN AN ATTEMPT TO DRAIN A SIGMOID ABSCESS. THE MD STATES THAT 3 MM OF THE INTRODUCER TIP SHEARED OFF AND WAS LEFT IN THE PT'S INTRAPERITONEAL CAVITY. MD WAS UNABLE TO RETRIEVE THE FRAGMENT USING A VASCULAR SNARE DEVICE. MD STATES THAT PT WEIGHS APPROXIMATELY (B)(6). PT LATER UNDERWENT A SCHEDULED OPEN SURGICAL PROCEDURE. SURGEON WAS UNSUCCESSFUL AT REMOVING THE FRAGMENT AT THIS TIME AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKATER INTRODUCER SYSTEM INTRODUCER SYSTEM DYB ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 651506000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention