BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLCANO VISIONS PV .018 DIGITAL IVUS CATHETER

    MDR report key: 6334817 · Received February 15, 2017

    Report

    Report Number
    2939520-2017-00023
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    December 5, 2016
    Report Date
    December 15, 2016
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    UDI-DI
    00184360000037
    PMA / PMN Number
    K150442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. NO TESTS/LABORATORY DATA WAS AVAILABLE. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE.

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A THERAPEUTIC PROCEDURE. THE CATHETER WAS USED FOR DIAGNOSTIC PURPOSES. A SECOND ATTEMPT WAS MADE POST-PROCEDURE BUT A PORTION OF THE SENSORS WERE "KNOCKED OUT" AND DID NOT PRODUCE AN IMAGE. THE DEVICE WAS DISCARDED AND A NEW ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENTS REPORTED. THE RETURNED DEVICE WAS INSPECTED AND THERE WERE BENDS PRESENT 118 MM DISTAL TO THE LUER AND 604 MM FROM THE DISTAL END, A PORTION OF THE FLOPPY TIP WAS BROKEN OFF 3 MM DISTAL TO THE SCANNER AND WAS NOT RETURNED, THERE WAS STRETCHING ON THE FLOPPY TIP NEAR THE SITE OF THE BREAK, THERE WAS A DENT ON THE SCANNER BODY BETWEEN THE PZT AND DIES. THE DEVICE PASSED THE GUIDEWIRE AND WIRE BOND TESTS. SEVERAL ELEMENTS FAILED TO MEET ECHO THRESHOLDS DURING THE APT TEST. THE DEVICE WAS RECOGNIZED BY THE IMAGING SYSTEM AND PRODUCED AN INTERMITTENT INCOMPLETE IMAGE. THE IMAGING COMPLAINT WAS DUPLICATED AND CONFIRMED BY THE INVESTIGATION. THE PROBABLE CAUSE OF THE FAILURE WOULD BE DAMAGE IN USE AS EVIDENCED BY A DENT ON THE SCANNER BETWEEN THE DIES AND PZT ELEMENTS. THE PROBABLE CAUSE OF THE FLOPPY TIP SEPARATION ON THE DEVICE WOULD BE DAMAGE IN USE. NO RESISTANCE WAS NOTED BY THE CUSTOMER DURING THE PROCEDURE OR ENCOUNTERED DURING THE GUIDEWIRE TEST. THERE WERE NO DEFECTS OBSERVED ON THE DEVICE THAT COULD HAVE FEASIBLY CONTRIBUTED TO THE OBSERVED DAMAGE. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. IT COULD NOT BE DETERMINED WHEN THE DAMAGE OCCURRED AFTER LEAVING THE MANUFACTURING FACILITY AND PRIOR TO RECEIPT AT THE COMPLAINTS FACILITY. THE INSTRUCTIONS FOR USE (IFU) STATES THE CATHETER DEVICE IS A DELICATE SCIENTIFIC INSTRUMENT AND SHOULD BE TREATED AS SUCH. ALWAYS OBSERVE THE FOLLOWING PRECAUTIONS: PROTECT THE CATHETER TIP FROM IMPACT AND EXCESSIVE FORCE. DO NOT CUT, CREASE, KNOT, OR OTHERWISE DAMAGE THE CATHETER. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION BECAUSE A PORTION OF THE FLOPPY TIP WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116949 VOLCANO VISIONS PV .018 DIGITAL IVUS CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 86700 0003 50081737 00184360000037

    Patients

    Seq Age Sex Outcome Treatment
    1