BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE II PRO BALLOON DILATATION CATHETER

    MDR report key: 21915851 · Received April 27, 2025

    Report

    Report Number
    3003775186-2025-00138
    Event Type
    Malfunction
    Date Received
    April 27, 2025
    Report Date
    April 27, 2025
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD
    Product Code
    LOX
    UDI-DI
    06934955942037
    PMA / PMN Number
    K180921
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTENDED PROCEDURES WERE LEFT HEART CATHETERIZATION, BYPASS GRAFT ANGIOGRAPHY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) OF THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). THE 1.0 X10 MM SAPPHIRE BALLOON CAME OFF OF THE DELIVERY CATHETER AND WAS PERMANENTLY LODGED IN RPDA. BACKGROUND: 1. OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: CABG [CORONARY ARTERY BYPASS GRAFT] X 2004, PCI [PERCUTANEOUS CORONARY INTERVENTION] WITH STENT, HYPERLIPIDEMIA. 2. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: CORONARY HEART DISEASE; DIABETES; HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276271 SAPPHIRE II PRO BALLOON DILATATION CATHETER Catheters, transluminal coronary angioplasty, percutaneous LOX ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD 4231522404 06934955942037

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other