BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1993425 · Received February 16, 2011

    Report

    Report Number
    2134265-2011-00214
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: 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 PHYSICIAN ACCESSED THE FEMORAL ARTERY. THE 90% STENOSED DENOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN USED A STERLING MR 6.0X40X135 BALLOON FOR POST DILATATION. THE BALLOON WAS INFLATED TO 14ATMS FIVE TIMES. ON THE SIXTH INFLATION THE BALLOON RUPTURED AFTER BEING INFLATED 30 SECONDS. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031604010 13353855

    Patients

    Seq Age Sex Outcome Treatment
    1 6FR MEDIKIT INTRODUCER| CRUISE GUIDEWIRE