BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1937306 · Received December 23, 2010

    Report

    Report Number
    2024168-2010-02957
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 3.25 X 15 MM VOYAGER NC (1011755-15, 0083162) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON, WHICH IS CONSISTENT WITH PREPARATION AND LEAK OR RUPTURE WHILE IN THE PATIENT ANATOMY. THE BALLOON WAS LOOSELY FOLDED. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED OUT OF A PINHOLE IN THE MIDDLE OF THE BALLOON, CONFIRMING THE REPORTED RUPTURE. THERE WAS A RADIAL SCRATCH ON THE PINHOLE 0.5 MM IN LENGTH. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH THE STENT OR OTHER DEVICES. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING OR PRODUCT RELATED DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE (RBP) AND BALLOON INTEGRITY. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT LIKELY DAMAGED PRIOR TO USE. IN THIS CASE, THE PATIENT ANATOMY WAS MODERATELY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED RUPTURE. IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR PATIENT ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 14 ATMOSPHERES WHICH IS BELOW THE RBP OF 18 ATMOSPHERES. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A MODERATELY CALCIFIED LESION, THE 3.25 X 15 MM VOYAGER NC RUPTURED AT 17 ATMOSPHERES. THE 3.0 X 15 MM VOYAGER NC ALSO RUPTURED AT 14 ATMOSPHERES. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0061562

    Patients

    Seq Age Sex Outcome Treatment
    1 3.25 X 15 MM VOYAGER NC (1011755-15, 0083162)