BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1913340 · Received November 11, 2010

    Report

    Report Number
    2024168-2010-02411
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 3.0 X 12 MM VOYAGER NC (PART 1011754-12, LOT 9051662) AND THE 3.0 X 15 MM VOYAGER NC (PART 1011754-15, LOT 9052661) ARE EACH BEING FILED UNDER SEPARATE MFR#'S. EVAL SUMMARY: FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MFG, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. RETURN OF THE VOYAGER RX 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 HEAVILY CALCIFIED, 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 12ATM WHICH IS BELOW THE RATED BURST PRESSURE (RBP) OF 14 ATM. A REVIEW OF THE PRODUCT MFG RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MFG CRITERIA. 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 RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WITH THE MID RIGHT CORONARY ARTERY WITH NO TORTUOSITY, HEAVY CALCIFICATION, CONCENTRIC, DE NOVO, AND 90% STENOSED. THE 3.0 X 12 MM VOYAGER NC WAS DELIVERED FOR THE PRE-DILATATION; HOWEVER, IT RUPTURED AT THE FIRST INFLATION AT 18 ATMOSPHERES (ATM). NEXT, THE 3.0 X 15 MM VOYAGER NC WAS DELIVERED AND INFLATED, BUT IT RUPTURED AT THE FIRST INFLATION AT 18 ATM. THEN, THE 2.75 X 15 MM VOYAGER RX WAS DELIVERED AND INFLATED, BUT IT RUPTURED AT THE FIRST INFLATION AT 12 ATM. SO, THE BALLOON WAS FINALLY CHANGED TO A NON-ABBOTT BALLOON AND IT WAS ABLE TO BE INFLATED AT 20 ATM. THERE WAS NO REPORTED PT EFFECT. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9031961

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 3.0 X15 MM VOYAGER NC(PART 1011754-15,LOT 9052661)| 3.0 X12 MM VOYAGER NC(PART 1011754-12,LOT 9051662)| DILATATION CATHETER: POWERED LACROSS| GUIDE WIRE: SION| GUIDE CATH: MACH I 7F| FR4