BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2912180 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00270
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED RUPTURE WAS CONFIRMED. BASED ON VISUAL, FUNCTIONAL AND SCANNING ELECTRON MICROSCOPY (SEM) 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 THIS COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION. DURING USE WITH THE 1.5 X 12 MM VOYAGER BALLOON CATHETER, RESISTANCE WAS NOTED WITH THE CALCIFICATION DURING ADVANCEMENT. THE VOYAGER WAS INFLATED TO 14 ATMOSPHERES (ATM) ONE TIME; HOWEVER, A BALLOON RUPTURE OCCURRED. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE CALCIFICATION AGAIN. THE BALLOON WAS PREPARED PER THE INSTRUCTIONS FOR USE, PRIOR TO USE IN THE ANATOMY. A NEW 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
    19079 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1101761

    Patients

    Seq Age Sex Outcome Treatment
    1