BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1658704 · Received April 12, 2010

    Report

    Report Number
    2024168-2010-00736
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 18, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VOYAGER 3.25X20(PART# 1011755-20, LOT# 9091061) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: MATERIAL RUPTURE. TIME OF DEVICE ISSUE: DURING THE PROCEDURE; ADVERSE EVENT: NONE. IT WAS REPORTED THAT TWO VOYAGER BALLOON CATHETERS WERE BEING USED IN THE BYPASS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VESSEL WAS VIEWED WITH INTRAVASCULAR ULTRA SOUND (IVUS) AND TWO NON-ABBOTT BALLOON CATHETERS WERE ADVANCED, BUT THEY WOULD NOT CROSS. A NON-ABBOTT CUTTING BALLOON WAS ADVANCED AND DID NOT CROSS. A POWERSAIL WAS USED TO DILATE PROXIMAL TO THE LESION SITE IN THE PROXIMAL LAD AND A NON-ABBOTT STENT WAS DEPLOYED IN THE PROXIMAL LAD. A VOYAGER BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION JUST DISTAL TO THE DEPLOYED STENT AND THEN WAS PULLED BACK TO POST DILATE THE STENT; HOWEVER, THE BALLOON RUPTURED. A SECOND VOYAGER WAS USED AND THE SAME RESULT OCCURRED. THE LESION WAS PRE-DILATED AND THEN PULLED BACK TO POST-DILATED THE STENT, AND THE SECOND VOYAGER RUPTURED. THE PRESSURE OF INFLATION FOR THE VOYAGER DEVICES ARE UNK. REPORTEDLY, THERE WERE NO PT EFFECTS. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9091061

    Patients

    Seq Age Sex Outcome Treatment
    1 CYPHER STENT| POWERSAIL BALLOON| FLEXTONE BALLOON CATHETER (2)| VOYAGER 3.25X20 (PART# 1011755-20, LOT# 9091061)