BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR PVA MICROSPHERES

    MDR report key: 2840381 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07178
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    NAJ
    PMA / PMN Number
    K030966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE A PORTION AT THE TOP OF THE VIAL, WITHIN THE CAP, HAD BROKEN OFF, LEAVING A SHARP EDGE. THE BROKEN PIECE WAS NOT RETURNED WITH THE COMPLAINT SAMPLE. 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 PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN EMBOLIC TREATMENT PROCEDURE, VIAL BREAKAGE OCCURRED. WHILE UNSCREWING THE LID OF THE CONTOUR PVA MICROSPHERES VIAL IT WAS OBSERVED THAT THE GLASS UNDER THE LID WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER VIAL OF CONTOUR PVA MICROSPHERES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN EMBOLIC TREATMENT PROCEDURE, VIAL BREAKAGE OCCURRED. WHILE UNSCREWING THE LID OF THE CONTOUR PVA MICROSPHERES VIAL IT WAS OBSERVED THAT THE GLASS UNDER THE LID WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER VIAL OF CONTOUR PVA MICROSPHERES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR PVA MICROSPHERES AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS NAJ BOSTON SCIENTIFIC - CORK M0017600450 14195387

    Patients

    Seq Age Sex Outcome Treatment
    1