BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2032641 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02106
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 4, 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
    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. 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. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE RATED BURST PRESSURE (RBP). 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 A LEAK IN THE CATHETER 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 LESION/ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON SECOND INFLATION AT THE 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. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR BALLOON RUPTURES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN THE MID RIGHT CORONARY ARTERY WITH THE 3.0 X 15 MM VOYAGER BALLOON CATHETER, THE BALLOON RUPTURED AT 18 ATMOSPHERES (ATM) DURING SECOND INFLATION. THE DEVICE WAS REPLACED WITH A 3.0 X 12 MM VOYAGER THAT ALSO RUPTURED AT 18 ATM, BUT DURING ITS FIRST INFLATION. THE VESSEL WAS CHARACTERIZED AS BEING MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, DE NOVO AND 90% STENOSED. A NON-ABBOTT BALLOON WAS USED FOR PRE-DILATATION AND A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE 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 0083062

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR GUIDE WIRE: ATHLETEGUIDE CATH: AL LAUNCHER 6F