BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1581924 · Received January 5, 2010

    Report

    Report Number
    2024168-2010-00019
    Event Type
    Malfunction
    Date Received
    January 5, 2010
    Date of Event
    December 10, 2009
    Report Date
    December 11, 2009
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). RESULTS AND CONCLUSIONS SUMMATION - BALLOON RUPTURES CAN OCCUR AS A RESULT OF A MANUFACTURING DEFICIENCY (SUCH AS DAMAGE TO THE BALLOON DURING THE PROCESSING OF THE BALLOON MATERIAL) OR FROM USE OF THE DEVICE. THERE CAN BE AN INTERACTION WITH ANATOMY AND/OR ACCESSORY DEVICES, WHICH CAN DAMAGE OR WEAKEN THE BALLOON MATERIAL AND LEAD TO RUPTURE DURING INFLATION. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. POSSIBLY THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR THE PT ANATOMY, SUCH THAT THE BALLOON RUPTURED. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED BALLOON RUPTURE.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE TARGET LESION HAD NO TORTUOSITY AND WAS CALCIFIED WITH 90% STENOSIS. AFTER ANOTHER COMPANY'S STENT WAS IMPLANTED, A KISSING BALLOON TECHNIQUE (KBT) WAS PERFORMED WITH ANOTHER COMPANY'S DILATATION CATHETER AND A VOYAGER NC. WHEN BOTH BALLOONS WERE INFLATED AT 10 ATM, THE VOYAGER NC RUPTURED. THE BALLOON WAS CHANGED TO ANOTHER COMPANY'S DILATATION CATHETER, AND KBT WAS PERFORMED. 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 9071461

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE CATH: LAUNCHER 7F JL4| STENT: CYPHER| GUIDE WIRE: RUNTHROUGH| DIL CATH: BP22