BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIDGEPOINT MEDICAL INC STINGRAY SYSTEM

    MDR report key: 2582770 · Received May 18, 2012

    Report

    Report Number
    3007210311-2012-00002
    Event Type
    Other
    Date Received
    May 18, 2012
    Date of Event
    April 20, 2012
    Report Date
    May 16, 2012
    Manufacturer
    BRIDGEPOINT MEDICAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K10272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN EFFORT TO UNDERSTAND AND ACCURATELY CHARACTERIZE BRIDGEPOINT MEDICAL DEVICE INVOLVEMENT, BRIDGEPOINT MEDICAL (B)(4) CONTACTED (B)(4) WHO HAD BEEN PRESENT AT THE CASE AND HAD FOLLOWED-UP WITH DR (B)(6) REGARDING THE PT'S STATUS, BOTH FELT THAT THE EVENT WAS DUE TO THROMBUS FORMATION IN THE GUIDE CATHETER.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON A CTO LESION LOCATED IN THE MID-RCA IN WHICH GUIDE CATHETERS WERE POSITIONED IN THE OSTIUMS OF BOTH CORONARY TREES AND A STINGRAY SYS WAS POSITIONED IN THE DISTAL RCA, THE GUIDE CATHETER THAT WAS POSITIONED IN THE OSTIUM OF THE RCA UNEXPECTEDLY "FLIPPED" OUT OF THE OSTIUM. THE PT STARTED COMPLAINING OF SEVERE CHEST PAIN, ANGIOGRAPHY SHOWED THROMBUS IN THE RCA AND THE LAD. THE PT STARTED HAVING VENTRICULAR TACHYCARDIA WHICH REQUIRED CARDIOVERSION X 1 WHICH CONVERTED THE PT'S RHYTHM TO SINUS. PCI GEAR WAS REMOVED FROM THE PT AND THROMBECTOMY OF THE RCA AND LAD WAS PERFORMED WITH GOOD RESULTS, THE PT SHOWED NO ADVERSE EFFECTS FROM THE EPISODE. PRIOR TO THE EVENT, CONTRALATERAL INJECTIONS WERE BEING PERFORMED VIA THE GUIDE CATHETER POSITIONED IN THE OSTIUM OF THE LEFT CORONARY TREE, THE GUIDE CATHETER THAT WAS POSITIONED IN THE OSTIUM OF THE RIGHT CORONARY TREE HAD BEEN LEFT IN POSITION WITH MINIMAL FLUSHING PROCEDURES. IT WAS FELT THAT THROMBUS FORMED IN THE GUIDE CATHETER POSITIONED IN THE RIGHT CORONARY TREE AND WHEN IT UNEXPECTANTLY "FLIPPED" OUT OF THE OSTIUM A PORTION OF THE THROMBUS WAS LEFT IN THE PROXIMAL LUMEN OF THE RCA AND A PORTION OF THE THROMBUS WAS EXPORTED TO THE LEFT CORONARY TREE. F/U ON THE STATUS OF THE PT 5 DAYS POST ADVERSE EPISODE IT WAS NOTED THAT THE PT WAS DOING WELL WITH NO RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGEPOINT MEDICAL INC STINGRAY SYSTEM STINGRAY CATHETER/STINGRAY GUIDEWIRE DQX BRIDGEPOINT MEDICAL INC. M-1000/M-3004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention