BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2032561 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02101
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 VOYAGER NC WILL BE FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED CATHETER NOTED BLOOD AND CONTRAST VISIBLE ON THE SHAFT, IN THE INFLATION LUMEN AND IN THE LOOSELY-FOLDED BALLOON, WHICH IS CONSISTENT WITH HANDLING, THE REPORTED USE OF THE DEVICE AND A LEAK OR RUPTURE IN THE BALLOON. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER WHEN FLUID LEAKED FROM A RADIAL RUPTURE IN THE BALLOON LOCATED 1 MM PROXIMAL TO THE DISTAL BALLOON MARKER, CONFIRMING THE REPORTED RUPTURE. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, PATIENT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. THE LESION WAS HEAVILY CALCIFIED AND LIKELY CONTRIBUTED TO THE REPORTED RUPTURE. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS CONFIRMED THAT THE BALLOON EXHIBITED A RADIAL LEAK IN THE BALLOON, INTERSECTING A FOLD. IT WAS DETERMINED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE ON THE OUTER SURFACE OF THE BALLOON. THE BALLOON MATERIAL WAS LIKELY DAMAGED (SCRATCHED) FROM AN INTERACTION WITH OTHER DEVICES AND/OR THE HEAVILY CALCIFIED LESION SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY. THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND DOES NOT APPEAR TO BE A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO VOYAGER NC'S RUPTURED WITH THE FIRST INFLATION AT 14 ATMOSPHERES (ATMS) AND 12 ATMS IN THE HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY. BOTH VOYAGER NCS WERE COMPLETELY REMOVED FROM THE PATIENT. NO OTHER BALLOONS WERE USED FOR FURTHER PREDILATATION. THE 2.75 X 12 VISION WAS THEN UNABLE TO CROSS THE PROXIMAL TO MID RCA TARGET LESION. A 3.0 X 12 VISION WAS ABLE TO CROSS AND WAS IMPLANTED IN THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION 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 1020861

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR