BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STINGRAY CATHETER

    MDR report key: 4133776 · Received October 1, 2014

    Report

    Report Number
    2134265-2014-05871
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K080987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE RE-ENTRY DEVICE WAS NOT VISIBLE UNDER FLUOROSCOPY. A STINGRAY CATHETER WAS SELECTED FOR USE. A DOUBLE NEGATIVE DRY PREP WAS PERFORMED USING A 20CC LUER LOCK SYRINGE AND A 3CC SYRINGE WITH 100% CONTRAST SOLUTION. THE 3-WAY STOPCOCK WAS PREPPED AND FILLED WITH 100% CONTRAST AND WHEN THE STOPCOCK WAS OPENED TO THE CATHETER THERE WAS VISUAL CONFIRMATION THAT THE PLUNGER DOVE TOWARD THE TIP OF THE CATHETER, INDICATING A PROPER PREP. THE STINGRAY WAS ADVANCED OVER A NON BSC WIRE INTO THE MID RIGHT CORONARY ARTERY (RCA). AN INFLATION DEVICE WAS CONNECTED TO THE STINGRAY CATHETER AND INFLATED TO 4ATM. UNDER FLUOROSCOPY THERE WAS NO VISUALIZATION OF THE STINGRAY BALLOON, REGARDLESS OF THE C-ARM POSITION. THE PHYSICIANS TRIED TO RE-PREP THE STINGRAY IN THE RCA TO AVOID HAVING TO REMOVE AND RE-ADVANCE THE CATHETER. THE RE-PREP WAS ALSO MET WITH NO VISUALIZATION UNDER FLUOROSCOPY. CONSEQUENTLY, THE PHYSICIANS HAD TO REMOVE THE STINGRAY AND COMPLETE THE PROCEDURE WITH ANOTHER STINGRAY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611150 STINGRAY CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749M1000A0 B131780121

    Patients

    Seq Age Sex Outcome Treatment
    1