BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²?

    MDR report key: 3201287 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04600
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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 EVALUATED BY MFR.: THE MAVERICK 2 CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP) WITHIN AN OPENED MAVERICK 2 PRODUCT POUCH AND SHELF BOX. THE BATCH NUMBER ON THE RETURNED PRODUCT POUCH AND SHELF BOX MATCHED THE INFORMATION ON THE DEVICE. THERE WAS A 8CM BLACK PIECE OF FM (FOREIGN MATTER) (HAIR) INSIDE THE SHELF BOX FLAP THAT OPENS AND CLOSES THE BOX. THE POSITION OF THE CARRIER TUBE INSIDE THE PRODUCT POUCH INDICATED THAT THE CARRIER TUBE HAD BEEN REMOVED FROM THE PRODUCT POUCH AND PUT BACK IN. BECAUSE THE RETURNED PACKAGING WAS OPENED AND THE DEVICE REMOVED, IT CANNOT BE DETERMINED DEFINITELY WHERE THE FM ORIGINATED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGE. IT WAS NOTED THAT AN OBJECT LOOKED "LIKE A HAIR" WAS FOUND IN THE STERILE PACKAGE OF THE 2.00MM X 20MM MAVERICK² BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGE. IT WAS NOTED THAT AN OBJECT LOOKED "LIKE A HAIR" WAS FOUND IN THE STERILE PACKAGE OF THE 2.00MM X 20MM MAVERICK²¿ BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300854 MAVERICK²? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892820200 15613277

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR