BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 3152001 · Received May 1, 2013

    Report

    Report Number
    3152001
    Event Type
    Other
    Date Received
    May 1, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AN UNANTICIPATED RETAINED FOREIGN BODY DURING AN EMERGENT CATH PROCEDURE. THE STENT DISLODGED FROM THE BALLOON IN THE AREA OF THE VEIN GRAFT AND THE RIGHT CORONARY ARTERY. THE MD WAS UNABLE TO RETRIEVE IT WITH A SECOND WIRE AND PULL THE WIRES, STENT AND CATHETER BACK TO THE AREA OF THE RIGHT EXTERNAL ILIAC ARTERY WHERE IT GOT LODGED JUST ABOVE THE INGUINAL LIGAMENT (FEMORAL AREA). THE DECISION WAS MADE TO CUT THE WIRE AND SECURE THE WHOLE DEVICE FOR REMOVAL BY A THORACIC SURGEON. THE THORACIC SURGEON RESPONDED AND REMOVED IT AND THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT INCIDENT AND WAS DISCHARGED HOME ON (B)(6) 2013. FULL DISCLOSURE OF THE EVENT WAS COMPLETED TO PATIENT AND SPOUSE WITH ALL QUESTIONS ANSWERED. SPOUSE CONSENTED TO ADDITIONAL PROCEDURE TO REMOVE THE RETUNED DEVICE. THE DEVICE WAS REPORTED TO THE VENDOR. THIS ITEM WAS NOT ON AN ALERT OR RECALL NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191034 BOSTON SCIENTIFIC VERIFLEX MR STENT MAF BOSTON SCIENTIFIC VERIFLEX MR 14888986

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other