BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK (R)

    MDR report key: 2162411 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-03113
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR#: 2134265-2011-02618. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, CATHETER ENTRAPMENT WITH A GUIDE WIRE OCCURRED AND A GUIDE WIRE TIP DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL AND A DIAGNOSTIC WAS PERFORMED OF THE LEFT CORONARY SYSTEM WHICH IDENTIFIED A LESION IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. A 300CM LUGE GUIDE WIRE WAS INSERTED AND A 2.5X15MM MAVERICK OTW BALLOON CATHETER WAS ADVANCED OVER THE WIRE TO THE LESION. ONE INFLATION WAS MADE AND AN ATTEMPT WAS MADE TO REMOVE THE CATHETER; HOWEVER THE CATHETER BECAME STUCK ON THE WIRE. ATTEMPTS WERE MADE TO FREE THE CATHETER FROM THE WIRE WITH SOME FORCE UNSUCCESSFULLY. THE DEVICES WERE BEING REMOVED FROM THE PATIENT TOGETHER WHEN THE TIP OF THE LUGE WIRE DETACHED IN THE AORTA. THE PATIENT WAS SCHEDULED FOR BYPASS SURGERY, SO THE TIP WAS LEFT FOR REMOVAL DURING THIS PROCEDURE. THE PATIENT UNDERWENT SUCCESSFUL CABG AND REMOVAL OF THE GUIDE WIRE TIP. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT REMAINED STABLE THROUGHOUT. THE PATIENT HAS SINCE BEEN RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK (R) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7492062015250 14193697

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR LUGE GUIDE WIRE