BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2580574 · Received May 18, 2012

    Report

    Report Number
    2024168-2012-03191
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    April 23, 2012
    Report Date
    April 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    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. THE REPORTED BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL INSPECTION, FUNCTIONAL TESTING, AND SCANNING ELECTRON MICROSCOPY IMAGING 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. 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). THE ADDITIONAL VOYAGER NC 2.75 X 12MM IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. 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 DURING AN INTERVENTIONAL PROCEDURE IN AN ECCENTRIC, MILDLY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY, THE VOYAGER NC 2.75 X 12 MM DEVICE WAS ADVANCED. THE VOYAGER NC BALLOON COULD NOT BE FULLY INFLATED. ANGIOGRAPHY SHOWED THAT THERE WAS A LEAK OF THE CONTRAST. THE DEVICE WAS REMOVED AND ANOTHER VOYAGER NC BALLOON WAS ADVANCED. THE SECOND VOYAGER NC BALLOON COULD NOT BE FULLY INFLATED. ANGIOGRAPHY SHOWED THAT THERE WAS A LEAK OF THE CONTRAST. THE DEVICE WAS REMOVED AND A THIRD VOYAGER NC BALLOON WAS ADVANCED SO THAT THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR ADVERSE PATIENT EFFECT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1110761

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR STENT: XIENCE V