BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2132856 · Received June 17, 2011

    Report

    Report Number
    2134265-2011-02530
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).INVESTIGATION COMPLETE- THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS.REVIEW OF THE INFORMATION AVAILABLE FOR THE REPORTED EVENT WAS UNABLE TO DETERMINE AN EXACT ROOT CAUSE. THERE WAS NO EVIDENCE OF ANY SPECIFICATION NON-CONFORMANCES RELATED TO THE COMPLAINT DEVICE; IT IS LIKELY THAT THE DEVICE MET SPECIFICATION BUT PERFORMANCE WAS LIMITED BY INTERACTION WITH PATIENT ANATOMY, INTERACTION WITH OTHER DEVICES OR OTHER PROCEDURAL FACTORS.THE MOST PROBABLE ROOT CAUSE WAS CONSIDERED OPERATIONAL CONTEXT. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A BALLOON RUPTURE OCCURRED. THE STERLING ES OTW 3MM X 40MM X 145CM BALLOON WAS INFLATED AND THE BALLOON RUPTURED. LESION SPECIFICS AND TO WHAT NUMBER OF ATMS IS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134304010 14328475

    Patients

    Seq Age Sex Outcome Treatment
    1