BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 2883330 · Received December 21, 2012

    Report

    Report Number
    3007798852-2012-00011
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MDT ABLATION FRONTIERS MFG
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DOUBLE TRANSEPTAL PUNCTURE WAS OBTAINED AND THE PHYSICIAN INITIALLY HAD SOME DIFFICULTY ADVANCING THE SHEATH ACROSS THE SEPTUM. THE SHEATH CROSSED THE SEPTUM ONCE THE WIRE WAS MOVED TO A MORE DISTAL AND SUPERIOR POSITION WITHIN WHAT APPEARED TO BE THE LSPV. IT WAS NOT OBVIOUS WHETHER THE ORIGINAL WIRE POSITION WAS IN THE LAA OR THE LSPV. AFTER NORMAL FLUSHING AND PREP, THE CRYOABLATION CATHETER AND MAPPING CATHETER WERE INTRODUCED INTO THE LA AND 2 FREEZES WERE APPLIED TO THE LSPV. AFTER THE FIRST 2 FREEZES, SIGNALS WERE STILL NOTED WITHIN THE PV AND A MORE INFERIOR VEIN BRANCH (STILL LSPV) WAS WIRED AND 2 MORE APPLICATIONS WERE GIVEN. AN INFERIOR BRANCH OF THE LIPV WAS WIRED AND 2 APPLICATIONS WERE GIVEN. THE BALLOON WAS CLEARLY OUTSIDE THE TUBULAR PORTION OF THE VEIN FOR ALL APPLICATIONS. THE PHYSICIAN WAS NOTIFIED OF A DROP IN BLOOD PRESSURE AS HE WAS PREPARING TO MOVE THE SYSTEM TO THE RSPV. THE REPORTED SYSTOLIC BP WAS IN THE 90'S WHEN IT HAD BEEN IN THE 150'S. AT THIS TIME, THE PHYSICIAN REPOSITIONED THE ICE CATHETER AND A PERICARDIAL EFFUSION WAS NOTED. PERICARDIOCENTESIS WAS PERFORMED WITH BLOOD REMOVAL OF 600CC. THE PATIENT STABILIZED FOLLOWING THE PERICARDIOCENTESIS AND WAS TRANSFERRED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MDT ABLATION FRONTIERS MFG 990063-020 0006474654

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention ARCTIC FRONT ADVANCE 2AF284, FLEXCATH SHEATH 3FC12