BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH CSG

    MDR report key: 1915563 · Received November 5, 2010

    Report

    Report Number
    2529252-2010-00013
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    September 17, 2010
    Report Date
    November 3, 2010
    Manufacturer
    THOMAS MEDICAL PRODUCTS
    Product Code
    DYB
    PMA / PMN Number
    K003731
    Removal / Correction Number
    Z-0661-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THE PROPER MATERIALS AND MANUFACTURING METHODS WERE USED TO PRODUCE THIS LOT OF MATERIALS. EVAL OF THE RETAIN DEVICES DID NOT SHOW ANY BRITTLENESS OF THE RO/SOFT MATERIAL. PULL FORCES OF RO/SHEATH JOINT WAS ABOVE THE MINIMUM SPECIFICATION. THE ROOT CAUSE IS THAT A FORCE APPLIED TO TIP SEGMENT EXCEED MATERIAL STRENGTH CAUSING THE RO TIP TO FRACTURE. DUE TO THE NATURE AND FREQUENCY OF THIS AND OTHER SIMILAR FIELD REPORTS, THOMAS MEDICAL PRODUCTS ISSUED A RECALL FOR THE SAFESHEATH CSG PRODUCT LINE ON (B)(6) 2009. THE LOT INVOLVED IN THIS INCIDENT WAS A PART OF RECALL (B)(4).

    Description of Event or Problem · 1

    INITIAL DESCRIPTION: "IT WAS REPORTED THAT SHEATH RADIO OPAQUE MATERIAL WAS BROKEN AND LEFT IN RIGHT ATRIUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESHEATH CSG PERCUTANEOUS INTRODUCER DYB THOMAS MEDICAL PRODUCTS S27186

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention