BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2063310 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01156
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW FOR THE REPORTED BATCH CONFIRMED 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 DURING A CORONARY ARTERY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED, SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WAS LOCATED IN POSTERIOR TIBIAL ARTERY. UPON 1ST INFLATION, THE STERLING 1.5MM X 20MM X 143CM BALLOON RUPTURED AT 6ATM. THE DEVICE WAS REMOVED, AND THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT CONDITION IS GOOD.

    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 H74939135152010 14047236

    Patients

    Seq Age Sex Outcome Treatment
    1 CRUISE SJM GUIDEWIRE| 4.5F PARENT SHEATH MEDIKIT INTRODUCER SHEATH