BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 3271686 · Received August 8, 2013

    Report

    Report Number
    2024168-2013-05010
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 11, 2013
    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 BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL/FUNCTIONAL/SEM 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. IT SHOULD BE NOTED THAT THE NC TREK CORONARY DILATATION CATHETER INSTRUCTIONS FOR USE (IFU) STATES: CAUTION: ALL AIR MUST BE REMOVED FROM THE BALLOON AND DISPLACED WITH CONTRAST PRIOR TO INSERTING INTO THE BODY; OTHERWISE, COMPLICATIONS MAY OCCUR. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 2.0X20 VOYAGER NC BALLOON DILATATION CATHETER (BDC) WAS PREPPED WHILE INSIDE OF THE PATIENT ANATOMY AND ADVANCED TO A 95% STENOSED, MILDLY CALCIFIED LESION IN A HEAVILY TORTUOUS UNSPECIFIED CORONARY ARTERY. DURING INFLATION USING AN UNSPECIFIED INFLATION DEVICE, THE BALLOON RUPTURED DURING THE 1ST INFLATION AT 18 ATMOSPHERES. THE VOYAGER NC WAS WITHDRAWN FROM THE ANATOMY WITH RESISTANCE FELT AGAINST THE VESSEL, HOWEVER, NO FORCE WAS APPLIED DURING THE WITHDRAWAL. ANOTHER VOYAGER NC WAS ABLE TO SUCCESSFULLY CROSS THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374765 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2071661

    Patients

    Seq Age Sex Outcome Treatment
    1