BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE

    MDR report key: 3111106 · Received May 9, 2013

    Report

    Report Number
    2939520-2013-00020
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    March 17, 2013
    Report Date
    April 11, 2013
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K100930
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS IT WAS DISCARDED BY THE HOSPITAL THEREFORE A DEVICE EVALUATION COULD NOT BE PERFORMED. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT WOULD REASONABLY BE EXPECTED TO CONTRIBUTE TO THE REPORTED EVENT. THE MANUFACTURER ACCOUNT MANAGER VISITED THE HOSPITAL ON (B)(4) 2013 AND REVIEWED THE ANGIOGRAM TO GIVE THE MANUFACTURER A MORE DETAILED DESCRIPTION OF THIS EVENT. IN HIS OPINION, THE HOSPITAL DOES NOT BELIEVE PWP PRESSURE GUIDEWIRE WAS THE CAUSE OF THIS INCIDENT. THE MANUFACTURER OF THE GUIDE LINER CATHETER WAS INFORMED OF THIS EVENT SHORTLY AFTER IT'S OCCURRENCE. THE MANUFACTURER REQUESTED A COPY OF THE ANGIOGRAM ASSOCIATED WITH THIS CASE; HOWEVER, THE HOSPITAL DID NOT AGREE TO THIS REQUEST. THIS CASE WAS REVIEWED BY THE MANUFACTURER'S CLINICAL AFFAIRS AND INDICATED THAT THE PRIMEWIRE PRESTIGE FUNCTIONED AS INTENDED. THE ANGIOGRAM WAS NOT ASSESSED, HOWEVER, WITH THE AVAILABLE FACTS GIVEN TO THE MANUFACTURER, IT APPEARS THAT THE PRIMEWIRE PRESTIGE WAS NOT THE CAUSE OF THE SPIRAL DISSECTION THAT ULTIMATELY RESULTED IN THE DEATH OF THE PT. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED WITH CHEST PAIN AND IT WAS DETERMINED THAT THE PT HAD A NON-ACUTE, NON-STEMI EVENT. INITIAL ANGIOGRAPHIC FINDINGS SHOWED POSSIBLE LESION IN THE OSTIAL CIRCUMFLEX. MODERATE LESION IN MID-CIRCUMFLEX AT BIFURCATION OF OM1. PHYSICIAN DECIDED TO PERFORM AN FFR PROCEDURE, USING A PRIMEWIRE PRESTIGE (PWP) GUIDEWIRE WHICH FUNCTIONED NORMALLY, THE PHYSICIAN OBTAINED THE RESULTS (FFR READING WAS NOT REPORTED COULD NOT GET THE PWP GUIDEWIRE TO MAKE THE ACUTE TURN AT THE SECOND LESION AT THE BIFURCATION. THE TRANSDUCER WOULD NOT CROSS THE LESION. PHYSICIAN ENGAGED A VASCULAR SOLUTIONS GUIDE LINER CATHETER OVER THE PWP PRESSURE GUIDEWIRE, FOR ADDITIONAL SUPPORT. CONTRAST WAS INJECTED THROUGH THE CATHETER AND A DISSECTION WAS NOTED AT OSTIAL CIRCUMFLEX. THE PWP PRESSURE GUIDEWIRE WAS IN THE CIRCUMFLEX ARTERY, DISTAL. THE FIRST NOTED DISSECTION WAS AT THE TIP OF THE GUIDE LINER CATHETER. AT THAT POINT, THE PRESSURE GUIDE WIRE AND THE CATHETER WERE BOTH REMOVED FROM THE BODY. THE CIRCUMFLEX WAS THEN WIRED WITH A BALANCE MIDDLEWEIGHT GUIDEWIRE (ANOTHER MANUFACTURER'S GUIDEWIRE). AN ATTEMPT WAS MADE TO BALLOON ANGIOPLASTY THE DISSECTED AREA, DISTAL FLOW REMAINED PATENT; HOWEVER, THERE WAS A NOTICEABLE SPIRAL DISSECTION. THE PHYSICIAN ENGAGED A SECOND GUIDE LINER CATHETER, AND SUCCESSFULLY BALLOONED THE LESION. AT THAT POINT, IT WAS NOTICED THAT THE DISSECTION HAD PROGRESSED TO THE LEFT MAIN, INCLUDING THE AORTA. IT WAS REPORTED THAT THE PT WAS TRANSFERRED TO (B)(6), WHERE THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204862 PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 8185 114 50347

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BMW GUIDEWIRE| VASCULAR SOLUTIONS GUIDE-LINER