BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2970653 · Received February 20, 2013

    Report

    Report Number
    2024168-2013-01004
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    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. THE OTHER 2.5 X 15 VOYAGER NC BALLOON CATHETER REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL, FUNCTIONAL AND SCANNING ELECTRON MICROSCOPY IMAGING ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS, MODERATE TORTUOSITY AND MODERATE CALCIFICATION. TWO 2.5 X 15 VOYAGER NC BALLOON CATHETERS WERE ADVANCED; HOWEVER, THE BALLOONS RUPTURED ON THE FIRST INFLATION AT 22 ATMOSPHERES. THIS WAS DIRECT-STENTING, NO PRE-DILATATION PERFORMED. A NEW 2.5 X 15 VOYAGER NC WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74739 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2080661

    Patients

    Seq Age Sex Outcome Treatment
    1