BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿ ES

    MDR report key: 2221544 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03499
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 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)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STERLING ES BALLOON CATHETER WAS RECEIVED FOR ANALYSIS. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE MIDSECTION OF THE BALLOON NEAR THE DISTAL EDGE OF THE MARKERBAND. VISUAL INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE DAMAGE. THE MANUFACTURING RECORD 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 INTERVENTION TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A NON-BSC GUIDE WIRE WAS INSERTED THROUGH A NON-BSC SHEATH AND SUCCESSFULLY CROSSED THE LESION. THE 2MM X 40MM X 145CM STERLING ES MONORAIL BALLOON RUPTURED AT 6ATM ON THE INITIAL INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INTERVENTION TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A NON-BSC GUIDE WIRE WAS INSERTED THROUGH A NON-BSC SHEATH AND SUCCESSFULLY CROSSED THE LESION. THE 2MM X 40MM X 145CM STERLING ES MONORAIL BALLOON RUPTURED AT 6ATM ON THE INITIAL INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135204010 14261713

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: 0.014INCH 175CM CRUISE| INTRODUCER SHEATH: 6F 25CM TERUMO| STENT: SMART