BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2822847 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07012
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110617
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% CONCENTRIC LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. A XIENCE PRIME STENT WAS IMPLANTED IN THE PROXIMAL TO DISTAL CX LESION, INTENTIONALLY JAILING THE OBTUSE MARGINAL VESSEL, TO TREAT THE LESION IN THE CX. A GUIDE WIRE WAS ADVANCED THROUGH THE STENT STRUTS TO THE LAD. THE 2.0 X 15 MM VOYAGER BALLOON WAS PREPARED PRIOR TO USE, PER THE INSTRUCTIONS FOR USE. THE VOYAGER WAS ADVANCED WITHOUT ISSUE TO THE MID CX AND INFLATED. THE BALLOON WAS INFLATED FOR THE FIRST TIME TO 8 ATMOSPHERES; HOWEVER, THE BALLOON RUPTURED. THE VOYAGER WAS REMOVED WITHOUT ISSUE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 1080161

    Patients

    Seq Age Sex Outcome Treatment
    1