BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCARDIA MORPH ACCESSPRO

    MDR report key: 2622327 · Received June 14, 2012

    Report

    Report Number
    3003610571-2012-00001
    Event Type
    Injury
    Date Received
    June 14, 2012
    Date of Event
    May 14, 2012
    Report Date
    June 14, 2012
    Manufacturer
    BIOCARDIA, INC.
    Product Code
    DYB
    PMA / PMN Number
    K090999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED BY BIOCARDIA, PHOTOGRAPHED AND DISINFECTED. ENTIRE DEVICE WAS RECEIVED ON A GUIDEWIRE WITH THE DISTAL SECTION SEPARATED FROM THE SHAFT BUT CONNECTED BY AN UNWOUND INNER COULD WHICH WAS WRAPPED AROUND GUIDEWIRE. SIGNIFICANT DAMAGE TO THE OUTER JACKET WAS NOTED BOTH PROXIMAL AND DISTAL TO THE POINT OF SEPARATION. CREASING AND HOLES THROUGH THE CATHETER WERE NOTED. PULL WIRE WAS BROKEN IN A CHARACTERISTIC DUCTILE FAILURE. BASED ON THE PHYSICIAN'S NARRATIVE AND THE CONDITION OF THE DEVICE AS RETURNED, BIOCARDIA HAS CONCLUDED THAT DURING REMOVAL OF THE MAP645, IT BECAME ENTRAPPED IN THE AORTOBIFEMORAL GRAFT IN AN AREA CLOSE TO THE SITE OF PERCUTANEOUS INTRODUCTION OF THE MAP645. INTERFERENCE WITH THE GRAFT DAMAGED THE OUTER JACKET OF THE DEVICE AND SUBSEQUENT ATTEMPTS TO RETRIEVE THE DEVICE RESULTED IN A SEPARATION OF THE DISTAL SECTION. THE FORCE USED WHILE ATTEMPTING TO RETRIEVE THE DEVICE EXCEEDED THE SPEC OF BOTH THE CATHETER AND THE STAINLESS STEEL PULL WIRE. CONCLUSIONS/ROOT CAUSE: THE ROOT CAUSE OF THIS FAILURE IS ROUGH HANDLING AFTER PROBABLE ENTRAPMENT IN A STENT GRAFT BIFURCATION WHICH CONCURS WITH THE PHYSICIAN'S OBSERVATION IN THE ORIGINAL COMPLAINT THAT THE CAUSE WAS POSSIBLY RELATED TO THE DEVICE GETTING "CAUGHT UP IN THE GRAFT ANATOMY."

    Description of Event or Problem · 1

    AS PART OF PERFORMING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A 6F 45 MM WORKING LENGTH BIOCARDIA MORPH ACCESSPRO STEERABLE INTRODUCER (B)(4) WAS INTRODUCED CONTRALATERALLY, LIKELY AT THE LOCATION OF AN EXISTING AORTOBIFEMORAL GRAFT. THE DEVICE TRAVERSED A STEEP AORTOBIFEMORAL JUNCTION AND THE DISTAL TIP WAS PLACED AT THE MID POINT OF THE RIGHT SIDE OF THE AORTOBIFEMORAL GRAFT. AFTER SUCCESSFUL WIRING OF A LESION IN THE DISTAL VASCULATURE, SEQUENTIAL BALLOON INFLATIONS RESULTED IN A SUCCESSFUL OUTCOME AND THE DEVICES WERE REMOVED. DURING REMOVAL OF THE MAP645, THE DISTAL SECTION BECAME ENTRAPPED AND SUBSEQUENT ATTEMPTS TO REMOVE IT PERCUTANEOUSLY RESULTED IN SEPARATION OF THE OUTER JACKET AND LINER BETWEEN THE DISTAL TIP AND THE MAIN SHAFT. THESE SECTIONS REMAINED CONNECTED BY THE INNER COIL AND ALL PORTIONS OF THE DEVICE REMAINED ON THE GUIDEWIRE. A SURGEON WAS CALLED WHO ACCESSED THE SITE OF THE ENTRAPMENT THROUGH THE GROIN AREA. THE DISTAL TIP WAS FREED AND THE ENTIRE DEVICE INCLUDING THE GUIDEWIRE WAS REMOVED. THE GRAFT WAS REPAIRED AND THE ACCESS SITE CLOSED. PT REMAINED STABLE THROUGHOUT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCARDIA MORPH ACCESSPRO STEERABLE INTRODUCER DYB BIOCARDIA, INC. MAP645 01037

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention ADVANTAGE GLIDEWIRE| SUPRACORE GUIDEWIRE| 5F INFINITI LIMA CATHETER| WHISPER GUIDEWIRE| EVERCROSS BALLOON PTA CATHETER