BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1899709 · Received November 5, 2010

    Report

    Report Number
    2024168-2010-02359
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 12, 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 3.0 X 18 MM XIENCE V (PART 1009541-18, LOT 0041241) IS BEING FILED UNDER A SEPARATE MFR #. EVAL SUMMARY: FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. RETURN OF THE VOYAGER NC CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE EVAL. 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. THE PT ANATOMY WAS MODERATELY TORTUOUS AND HEAVILY CALCIFIED AND THE VOYAGER NC WAS USED TO POST DILATE A STENT, WHICH LIKELY CONTRIBUTED TO THE REPORTED RUPTURE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR PT ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 12 ATMS WHICH IS BELOW THE RATED BURST PRESSURE (RBP). A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE LEFT ANTERIOR DESCENDING ARTERY WHICH HAD MODERATE TORTUOSITY, HEAVY CALCIFICATION, ECCENTRIC DE NOVO, AND 90% STENOSIS, AFTER PRE-DILATATION WITH A BALLOON CATHETER AN "INDENTATION" WAS STILL NOTED BUT A 3.0 X 18 MM XIENCE V WAS IMPLANTED. THE BALLOON RUPTURED DURING THE FIRST INFLATION OF 30 SECONDS AT 10 ATMOSPHERES (ATMS). THE PHYSICIAN ATTEMPTED TO POST-DILATE THE 3.0 X 12 MM VOYAGER NC AT THE LESION, BUT IT ALSO RUPTURED DURING THE FIRST INFLATION OF 30 SECONDS AT 12 ATMS. THERE WAS NO REPORTED PT EFFECT. THE PHYSICIAN USED A NON-ABBOTT BALLOON TO POST-DILATE THE LESION AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. 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 0050362

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FIELDER FC| GUIDE CATH: AXESS| GUIDE WIRE: RUNTHROUGH NS,| FORTIS| LOT 0041241)| DILATATION CATHETER: MAVERICK II,| STENT: 3.0 X 18 MM XIENCE V (PART 1009541-18,