BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIDGEPOINT MEDICAL, INC. STINGRAY SYSTEM

    MDR report key: 2632766 · Received June 21, 2012

    Report

    Report Number
    3007210311-2012-00004
    Event Type
    Other
    Date Received
    June 21, 2012
    Date of Event
    June 18, 2012
    Report Date
    June 21, 2012
    Manufacturer
    BRIDGEPOINT MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN EFFORT TO UNDERSTAND AND ACCURATELY CHARACTERIZE BRIDGEPOINT MEDICAL DEVICE INVOLVEMENT, BRIDGEPOINT MEDICAL (B)(4) ATTEMPTED TO CONTACT DR. (B)(6) ON (B)(4) 2012, WITH NO RESULT AS YET. DR. (B)(6) DID CONTACT HIS LOCAL BRIDGEPOINT REPRESENTATIVE ON (B)(4) 2012, AND REPORTED THAT THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON A CTO OF THE RCA IN WHICH THE BPM SYSTEM WAS USED THE PATIENT SUDDENLY BECAME HYPOTENSIVE, UPON A RETROGRADE INJECTION SOME CONTRAST EXTRAVASATION WAS NOTED IN THE MID-VESSEL AT APPROXIMATELY THE SITE OF THE INITIAL RE-ENTRY ATTEMPT, THE PATIENT CONTINUED TO BECOME HEMODYNAMICALLY UNSTABLE AND ACLS PROTOCOL WAS INITIATED. A PERICARDIOCENTESIS WAS PERFORMED WITH APPROXIMATELY 100CC OF FLUID REMOVED. PATIENT WAS RESUSCITATED AND ADMITTED TO CCU. THE CROSSBOSS WAS USED WITHOUT DIFFICULTY AND TRAVERSED THROUGH THE VESSEL TO THE IDENTIFIED LANDING ZONE; THE STINGRAY CATHETER WAS POSITIONED AND INFLATED. THE STINGRAY GUIDEWIRE WAS TRAVERSED THROUGH THE CATHETER AND RE-ENTRY TO THE TRUE LUMEN WAS PERFORMED THE STINGRAY GUIDEWIRE WAS REMOVED AND REPLACED WITH A PILOT 200 GUIDEWIRE FOR MANIPULATION TO THE DISTAL VESSEL. THE RE-ENTRY SITE OF THE STINGRAY GUIDEWIRE WAS NOT ABLE TO BE FOUND WITH THE PILOT 200 GUIDEWIRE UPON NUMEROUS ATTEMPTS. THE PILOT 200 GUIDEWIRE WAS REMOVED AND THE STINGRAY BALLOON DEFLATED AND REPOSITIONED SLIGHTLY DISTALLY TO THE FIRST RE-ENTRY SITE. A SECOND STINGRAY GUIDEWIRE (FIRST WIRE BECAME CONTAMINATED AFTER REMOVAL) WAS BROUGHT IN FOR A RE-ENTRY ATTEMPT THAT WAS NOT SUCCESSFUL. THE STINGRAY GUIDEWIRE WAS REMOVED AND A FIELDER XT WIRE WAS TRAVERSED INTO THE CATHETER AND THE STINGRAY CATHETER WAS REMOVED. THE CROSSBOSS CATHETER WAS REINTRODUCED TO CREATE A CHANNEL FURTHER DISTALLY IN THE VESSEL; THIS IS WHEN THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. ALL DEVICES WERE REMOVED FROM THE RCA AND A RETROGRADE INJECTION WAS DONE WHICH SHOWED A SMALL AMOUNT OF CONTRAST EXTRAVASATION AT APPROXIMATELY THE SITE OF THE INITIAL RE-ENTRY SITE. THE PATIENT CONTINUED TO BECOME HEMODYNAMICALLY UNSTABLE AND ACLS PROTOCOL WAS INITIATED. A PERICARDIOCENTESIS WAS PERFORMED WITH APPROXIMATELY 100CC OF FLUID REMOVED. THE PATIENT HAS BEEN RESUSCITATED AND WAS ADMITTED TO CCU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGEPOINT MEDICAL, INC. STINGRAY SYSTEM STINGRAY, STINGRAY WIRE DQY BRIDGEPOINT MEDICAL, INC. M1000 BP20112800062

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R STINGRAY WIRE: M3004, LOT #BP201121500039| STINGRAY WIRE: M3004, LOT #BP20113130075| CROSSBOSS CATHETER: M 2000, LOT #BP20120110008