BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3922854 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-03893
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K132430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION IS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150MM STERLING BALLOON CATHETER WAS SELECTED FOR DILATATION. THE DEVICE WAS SUCCESSFULLY INFLATED ON THREE OCCASIONS; HOWEVER, UPON INFLATING THE BALLOON THE FOURTH TIME, IT WAS NOTED THAT IT WOULD NOT INFLATE AT 10 ATMOSPHERES. THE PHYSICIAN INFLATED THE STERLING BALLOON CATHETER INSIDE A COVERED NON BSC STENT AND IT COULDN'T INFLATE AND THE DEVICE WAS PULLED OUT, IT WAS THEN NOTED THAT THE BALLOON HAD BURST AND HAD A HOLE. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 6.0X 300MM STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400616 STERLING? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939032602210 16563561

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR