BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2253516 · Received September 19, 2011

    Report

    Report Number
    2024168-2011-06391
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 25, 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: BMW UNIVERSAL. GUIDE CATH: TAIGA. STENT: XIENCE V. IN THIS CASE, THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, WHICH MAY SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, AS THE LESION WAS MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 99% STENOSED, THIS MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. IT WAS NOTED THAT THE BALLOON WAS INITIALLY SOAKED PRIOR TO USE AND PREPARED OUTSIDE OF THE BODY PER THE INSTRUCTIONS FOR USE. THERE WAS ALSO NO RESISTANCE NOTED DURING ADVANCEMENT AND REMOVAL OF THE DEVICE. IT IS POSSIBLE THAT THE BALLOON MATERIAL BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES, THE STENT IMPLANT AND/OR THE TORTUOUS AND CALCIFIED LESION SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED, ALTHOUGH THIS CANNOT BE CONFIRMED. AS THE PRODUCT WAS DISCARDED BY THE ACCOUNT, THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND MAY HAVE AIDED IN DETERMINING A CAUSE FOR THE RUPTURE. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATION, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY. A REVIEW OF THE FINISHED PRODUCT DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMANCES ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE ALSO DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. AFTER PREDILATATION, A XIENCE V STENT WAS IMPLANTED AND POST-DILATATION WAS PERFORMED WITH THE 4.0 X 8 MM VOYAGER NC BALLOON. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES, FOR 30 SECONDS. THERE WAS NO REPORTED RESISTANCE DURING ADVANCEMENT OR REMOVAL OF THE VOYAGER NC CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 1042861

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR