BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1825408 · Received September 1, 2010

    Report

    Report Number
    2024168-2010-01807
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 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
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. DEVICE #1 - VOYAGER NC (PART #1011754-15; LOT #0050461), IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE #2 ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING PRE-DILATATION IN THE PROXIMAL LAD, THE 3.0X15 VOYAGER NC WAS INFLATED TO 20 ATM AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 3.0X20 VOYAGER NC WAS INFLATED TO 20 ATM AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A NON-ABBOTT DILATATION CATHETER WAS SUCCESSFULLY INFLATED COMPLETING THE PRE-DILATATION. A 3.0X23 XIENCE V STENT WAS SUCCESSFULLY DEPLOYED AND THE PROCEDURE COMPLETED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0021061

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR SHEATH: 7 FR| DIL CATH: DEVICE #1 - VOYAGER| DURASTAR 3.0/20| GUIDE WIRE: WHISPER ES| INFLATION: PPK| (PART #1011754-15, LOT #0050461)| STENT: XIENCE V 3.0/23| GUIDE CATH: XB LAD 3.5 7 FR