BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTX? - 18

    MDR report key: 3810034 · Received May 14, 2014

    Report

    Report Number
    2134265-2014-02683
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    February 10, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K914786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A PLUNGER, COIL AND INTRODUCER WERE RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THE PLUNGER WAS KINKED. THE APEX ZAP TIP WAS VISIBLE IN THE HUB OF THE INTRODUCER. AN ATTEMPT WAS MADE TO ADVANCE THE COIL WITH THE PLUNGER THROUGH THE INTRODUCER HOWEVER THIS WAS NOT SUCCESSFUL AS RESISTANCE WAS MET. THE INTRODUCER HAD TO BE CUT IN ORDER TO RETRIEVE THE COIL RESULTING IN THE COIL BEING INADVERTENTLY CUT WHILE ATTEMPTING TO RETRIEVE IT. THIS LEFT THE APEX ZAP TIP AND A SECTION OF THE COIL REMAINING IN THE HUB OF THE INTRODUCER. THIS WAS RETRACTED WITH EASE AND THIS PART OF THE COIL WAS FOUND TO BE KINKED AND STRETCHED FROM THE PROCEDURE. THERE WAS BLOOD ON THE APEX ZAP TIP AND ON THE PROXIMAL FIBER BUNDLES, LIKELY FROM HANDLING. MICROSCOPIC INSPECTION FOUND NO ISSUES WITH THE ZAP TIPS. THE DIMENSIONS OF THE COIL THAT COULD BE MEASURED WERE FOUND TO BE IN SPECIFICATION. THE NUMBER OF FIBER BUNDLES RECORDED DURING PRODUCT ANALYSIS WAS BELOW THE ASSIGNED SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT THE COIL WAS OUT OF THE INTRODUCER. A 6MM/6.5 MM VORTX - 18 WAS SELECTED TO TREAT THE UNSPECIFIED TARGET LESION. DURING PREPARATION, THE DEVICE WAS UNPACKED AND IT WAS THEN NOTED THAT THE COIL WAS COMING OUT OF THE COIL INTRODUCER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE NUMBER OF FIBER BUNDLES WAS BELOW THE ASSIGNED SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288617 VORTX? - 18 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M0013812060 14699665

    Patients

    Seq Age Sex Outcome Treatment
    1