BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING SL BALLOON DILATATION CATHETER

    MDR report key: 2141700 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02475
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K093720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. ICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. 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 DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). A NON-BSC 6F INTRODUCER SHEATH AND NON-BSC GUIDE CATHETER WERE USED. A NON-BSC GUIDEWIRE WAS ADVANCED ACROSS THE LESION AND THE LESION WAS PRE-DILATED WITH A NON-BSC 2.0X40MM BALLOON. THE 4.0X120MM 90CM STERLING SL OTW BALLOON WAS ADVANCED AND WAS INFLATED TO 6 ATM, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED INTACT. THE DILATION WAS COMPLETED WITH A STERLING MR 4.0X120MM BALLOON AND TWO 6.0X100MM NON-BSC STENTS WERE PLACED IN THE SFA. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING SL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939148401290 0013284133

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH, SHEATHLESS PV 6F| GUIDE CATH: LUMINEX| BALLOON CATH: 2.0X40MM JENITY| GUIDEWIRE: TREASURE