BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2203013 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05687
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 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: SION BLUE, RUNTHROUGH. GUIDE CATH: PROFIT JL3.5. 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 RATED BURST PRESSURE (RBP). RETURN OF THE RX VOYAGER 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 MODERATELY CALCIFIED LESION SUCH THAT THE BALLOON RUPTURED UPON THE SECOND INFLATION AT 8 ATMOSPHERES WHICH IS BELOW 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. ALTHOUGH THE DEVICE WAS NOT RETURNED FOR ANALYSIS, BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL PRE-DILATATION IN THE 99% STENOSED, MODERATELY CALCIFIED AND TORTUOUS PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY AT 8 ATMOSPHERES (ATM) FOR 20 SECONDS, THE RX VOYAGER T BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATM, BELOW RATED BURST PRESSURE, FOR 3 SECONDS. THE DEVICE WAS COMPLETELY REMOVED WITHOUT DIFFICULTY AND THERE WERE NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0040961

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR