BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 3021532 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01840
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED A HOLE IN THE INNER AND OUTER SHAFT 3CM FROM THE PROXIMAL BALLOON BOND. THE DIAMETER OF THE HOLE WAS SLIGHTLY LARGER THAN THE OUTER DIAMETER WIRE AND MAY BE CONSISTENT WITH PERFORATION OF THE SHAFT WALL WITH THE END OF A GUIDEWIRE DURING CLINICAL USE OR PREPARATION FOR CLINICAL USE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT OR THE CONFIRMED DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE A SHAFT PERFORATION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN A VERY TORTUOUS AND "REALLY DISEASED" VESSEL. USING AN UNKNOWN GUIDE WIRE, THE PHYSICIAN ADVANCED A 8MM X 2.00MM EMERGE BALLOON CATHETER TO THE TARGET LESION. IT WAS NOTED THAT THE GUIDE WIRE EXITED THE SHAFT OF THE BALLOON CATHETER. THE DEVICE WAS SUCCESSFULLY REMOVED. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH OTHER DEVICE BUT WAS UNSUCCESSFUL AND THE PROCEDURE WAS UNABLE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE A SHAFT PERFORATION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN A VERY TORTUOUS AND "REALLY DISEASED" VESSEL. USING AN UNKNOWN GUIDE WIRE, THE PHYSICIAN ADVANCED A 8MM X 2.00MM EMERGE BALLOON CATHETER TO THE TARGET LESION. IT WAS NOTED THAT THE GUIDE WIRE EXITED THE SHAFT OF THE BALLOON CATHETER. THE DEVICE WAS SUCCESSFULLY REMOVED. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH OTHER DEVICE BUT WAS UNSUCCESSFUL AND THE PROCEDURE WAS UNABLE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124708 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919108200 14878357

    Patients

    Seq Age Sex Outcome Treatment
    1