BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER INTRODUCER SET

    MDR report key: 1592716 · Received January 27, 2010

    Report

    Report Number
    9613246-2010-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Report Date
    December 15, 2009
    Manufacturer
    PBN MEDICALS DENMARK A/S
    Product Code
    FGE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE CUSTOMER'S REPORT: THE BLACK RADIOGRAPH MARKER DETACHED FROM THE SKATER CATHETER. THE CAUSE OF THIS INCIDENT IS STILL UNDER REVIEW. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE DISTRIBUTOR IN ORDER TO BETTER UNDERSTAND AND EVALUATE THE CIRCUMSTANCES DURING THE PTCD PROCEDURE. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFO REGARDING THE CAUSE OF THIS INCIDENT BECOMES AVAILABLE. FURTHERMORE, IT IS NOTED THAT NO OTHER COMPLAINTS HAVE BEEN REPORTED IN RELATION TO THIS SPECIFIC LOT (P355378), AND NO SIMILAR ISSUES INVOLVING RADIOGRAPH MARKER DETACHMENT FROM THE SKATER CATHETER HAVE BEEN REPORTED TO US IN THE PAST.

    Description of Event or Problem · 1

    (B)(6). DURING A PTCD (PERCUTANEOUS TRANSHEPATIC CHOLANGIO DRAINAGE) PROCEDURE USING SKATER CATHETER, THE BLACK RADIOGRAPH MARKER HAVE COME OFF THE CATHETER. THERE IS A RISK OF EMBOLIZATION DEPENDING ON THE LOCATION OF THE MARKER. INTERVENTIONAL PROCEDURE MAY BE REQUIRED TO REMOVE THE MARKER IF IT IS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKATER INTRODUCER SET INTRODUCER SYSTEM FGE PBN MEDICALS DENMARK A/S 651506300 P355378

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention