BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2493088 · Received March 15, 2012

    Report

    Report Number
    2024168-2012-01699
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE SHAFT SEPARATION WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 LESION THE PROXIMAL LEFT MAIN, WHICH WAS MODERATELY CALCIFIED AND DID NOT OPEN UP DESPITE BEING PRE-DILATED WITH A CUTTING BALLOON. SUBSEQUENTLY, THE FIRST XIENCE SBA DID NOT CROSS. THE LESION WAS PRE-DILATED AGAIN, BUT THE 2ND XIENCE SBA DID NOT CROSS AS WELL. AN ATTEMPT WAS MADE TO CROSS WITH A XIENCE PRIME AND IT ALSO FAILED TO CROSS. A NON-ABBOTT STENT WAS ABLE TO CROSS, BUT AFTER IT WAS IMPLANTED, THROMBUS STARTED TO FORM. AN EXTRACTION CATHETER WAS USED TO REMOVE THE THROMBUS AND THEN A VOYAGER NC WAS TO BE USED FOR POST-DILATATION; HOWEVER, DURING PREPARATION, THE DISTAL END APPEARED TO BE BROKEN; THEREFORE IT WAS NOT USED. A NEW VOYAGER NC BALLOON WAS USED TO COMPLETE POST-DILATATION. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED DUE TO THROMBUS FORMATION AFTER THE NON-ABBOTT STENT WAS DEPLOYED, BUT NOT DUE TO ANY ISSUE WITH THE ABBOTT DEVICES. 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 1090661

    Patients

    Seq Age Sex Outcome Treatment
    1