BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARADRIVE SHEATH

    MDR report key: 22546081 · Received July 18, 2025

    Report

    Report Number
    MW5172961
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 6, 2025
    Report Date
    July 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6). NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON (B)(6). PRODUCT. THE PATIENT HAD AN ADVERSE EVENT. WHILE THE PHYSICIAN WAS ADVANCING THE FARAWAVE CATHETER THROUGH THE FARADRIVE SHEATH, THE PATIENT'S ECG SHOWED SUDDEN ONSET ST SEGMENT ELEVATION. THE OXYGEN WAS ADMINISTERED AND THE PATIENT WAS MONITORED UNTIL THE ELEVATION RESOLVED THEN THE PROCEDURE CONTINUED. THE PATIENT REMAINED STABLE FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN FELT THAT AIR WAS INTRODUCED TO THE SHEATH WHEN THE OCTARAY CATHETER AND THE FARAWAVE CATHETER WERE EXCHANGED. IN ADDITION, THE CARTO 3 SYSTEM DISPLAYED A SENSOR ERROR, CODE UNKNOWN, WHEN THE OCTARAY CATHETER WAS PLUGGED INTO THE PATIENT INTERFACE UNIT. THE CABLE WAS EXCHANGED WITHOUT RESOLUTION. THE CATHETER WAS EXCHANGED AND THE ISSUE RESOLVED. (B)(6) CATHETERS USED DURING THE PROCEDURE: OCTARAY F CURVE (D160906 LOT UNKNOWN), SOUNDSTAR (CATALOG AND LOT UNKNOWN), DECANAV (CATALOG AND LOT UNKNOWN) NON (B)(6) CATHETERS USED: BOSTON SCIENTIFIC FARADRIVE SHEATH AND THE FARAPULSE CATHETER. CARTO SN (B)(6) SOFTWARE VERSION: 8.1.0.325 NGEN SERIAL NUMBER AND SOFTWARE VERSION UNKNOWN PFA PROCEDURE WITH BOSTON SCIENTIFIC FARAPULSE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574002 FARADRIVE SHEATH CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARTO 3 SYSTEM.| DECANAV.| OCTARAY CATHETER.| SOUNDSTAR.