BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    (OYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1675444 · Received April 23, 2010

    Report

    Report Number
    2024168-2010-00831
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    March 29, 2010
    Report Date
    March 29, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VOYAGER NC 2.75 X 15 MM (PART # 1011753-15/LOT # 9060861) IS BEING FILED UNDER A SEPARATE MFR NUMBER. EVAL SUMMARY: THE DEVICE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVAL AND DETERMINATION OF CAUSE. BALLOON RUPTURES CAN OCCUR AS A RESULT OF A MFG DEFICIENCY (SUCH AS DAMAGE TO THE BALLOON DURING THE PROCESSING OF THE BALLOON MATERIAL) OR FROM USE OF THE DEVICE. DURING USE 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. REPORTEDLY THE LESION WAS MILDLY TORTUOUS AND HEAVILY CALCIFIED WITH 90% STENOSIS, WHICH LIKELY CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR THE PT ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON INFLATION AT 8 ATM, WHICH IS BELOW THE RATED BURST PRESSURE. A REVIEW OF THE PRODUCT MFG RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MFG CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, WITHOUT HAVING THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. ALL BALLOON CATHETERS ARE LEAK TESTED ON-LINE AND A SAMPLING OF UNITS FROM ALL CATHETER LOTS ARE RUPTURE TESTED PRIOR TO RELEASE FOR USE.

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE ECCENTRIC, DE NOVO LESION WAS LOCATED IN THE 1ST DIAGONAL OFF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, WHICH WAS MODERATELY TORTUOSITY, HEAVILY CALCIFICATION AND HAS A 90% STENOSIS. A ROTABLATOR WAS USED TO ABATE THE HEAVY CALCIFICATION OF THE LAD AND THEN THE NC VOYAGER NC 2.75 X 15 MM BALLOON CATHETER WAS USED, BUT IT RUPTURED AT 8 ATMOSPHERES (ATM) AFTER 5 SECONDS. ANOTHER NC VOYAGER 2.5 X 15 BALLOON CATHETER WAS USED, BUT IT WAS ALSO RUPTURED AT 8 ATM AFTER 5 SECONDS. A NON ABBOTT BALLOON CATHETER OF THE SAME SIZE WAS USED WITHOUT ISSUES. AFTER DILATATION WITH THE NON ABBOTT BALLOON WAS DONE A XIENCE V 2.5 X 23 MM STENT WAS DEPLOYED IN THE LESION AND THE PROCEDURE WAS COMPLETED. 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 (OYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9092361

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR GUIDE WIRE: RUNTHROUGH| STENT: XIENCE V 2.5 X 23 MM| (PART # 1011753-15/LOT # 9060861)| DILATATION CATHETER: VOYAGER NC 2.75 X 15 MM| QUANTUM MAVERICK 2.5 X 15 MM