BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2770771 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06242
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 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. GUIDE WIRE: BMW UNIVERSAL II, GUIDE CATH: MACH 1, STENT: CYPHER 3.0X23MM. IT IS INDICATED THAT THE DEVICE IS NOT RETURNED 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. 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% STENOSED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY AND HEAVY CALCIFICATION. A NON-ABBOTT STENT WAS DEPLOYED TO TREAT THE LESION. THE 3.0 X 15 MM VOYAGER NC BALLOON WAS PREPARED PER THE INSTRUCTIONS FOR USE, AND ADVANCED FOR POST-DILATATION. SOME RESISTANCE WAS NOTED WITH THE VESSEL. THE BALLOON WAS INFLATED FOR THE FIRST TIME TO 16 ATMOSPHERES (ATM); HOWEVER, A BALLOON RUPTURE OCCURRED. THE DEVICE WAS REMOVED WITHOUT ISSUE. 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 NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2043061

    Patients

    Seq Age Sex Outcome Treatment
    1