BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH CSG WORLEY

    MDR report key: 1950312 · Received December 14, 2010

    Report

    Report Number
    2529252-2010-00015
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 14, 2010
    Manufacturer
    THOMAS MEDICAL PRODUCTS
    Product Code
    DYB
    PMA / PMN Number
    K003731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THE PROPER MATERIALS AND MFG METHODS WERE USED TO PRODUCE THIS LOT OF MATERIALS. THE ROOT CAUSE IS THAT A FORCE APPLIED TO TIP SEGMENT EXCEED MATERIAL STRENGTH CAUSING THE RO TIP TO FRACTURE. EVAL OF THE RETAIN DEVICES DID NOT SHOW ANY BRITTLENESS OF THE RO/SOFT TIP MATERIAL. PULL FORCES OF RO/SHEATH JOINT WAS ABOVE THE MINIMUM SPECIFICATION. THE COMPLAINT SAMPLE IS UNAVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER DESCRIPTION: "AFTER IMPLANTATION OF ELECTRODE IN THE LEFT VENTRICLE AND REMOVAL OF THE SHEATH, AN X-RAY MARKER ON THE DISTAL END OF THE SHEATH REMAINED IN THE SINUS CORONARIUS; THIS IS STILL VISIBLE THERE ON THE THORACIC X-RAY, 48 HOURS POST-OP. AN ACUTE DANGER TO THE PT IS HOWEVER NOT TO BE ASSUMED." (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESHEATH CSG WORLEY PERCUTANEOUS INTRODUCER DYB THOMAS MEDICAL PRODUCTS S30849X1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention