BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2013564 · Received March 10, 2011

    Report

    Report Number
    2024168-2011-01551
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. GUIDE WIRE: RUN THROUGH, FIELDER; GUIDING CATHETER: LAUNCHER 6F SAL.75. 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, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. RETURN OF THE VOYAGER NC CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. 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. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, OR THE HEAVILY CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON INFLATION AT 12ATM WHICH IS BELOW THE RATED BURST PRESSURE OF 18 ATMOSPHERES. 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. WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE (RBP).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A HEAVILY TORTUOUS, CALCIFIED, 90% STENOSED, MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION, VESSEL DIAMETER OF 3.5 MM AND THE VESSEL LENGTH WAS 20 MM; AFTER THE GUIDE WIRE CROSSED THE TARGET LESION, A 2.5 X 15 MM VOYAGER NC WAS ADVANCED, BUT FAILED TO CROSS. AFTER REMOVAL FROM THE ANATOMY, THE TIP WAS FOUND TO BE COLLAPSED. A SECOND NON-ABBOTT BALLOON CATHETER WAS ATTEMPTED BUT THE "INDENTATION" [STENOSIS] REMAINED. A 3.5 X 15 MM VOYAGER NC WAS USED AND INFLATED TO 12 ATMOSPHERE (ATM) WHEN THE BALLOON RUPTURED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 9051261

    Patients

    Seq Age Sex Outcome Treatment
    1