BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2011037 · Received March 8, 2011

    Report

    Report Number
    2134265-2011-00518
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 8, 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 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 CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A CONTRALATERAL APPROACH. THE 100% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY AND WAS APPROXIMATELY 4CM LONG. A NON-BSC GUIDE WIRE SUCCESSFULLY CROSSED THE LESION. PRE DILATION WAS PERFORMED WITH A 3.0X40MM NON-BSC BALLOON CATHETER, AND A SPCB 4MM CUTTING BALLOON. THE 6.0 X 40/135 (4F) STERLING MR BALLOON CATHETER WAS ADVANCED AND INFLATED TWO TIMES, TO 6 ATMS AND 10 ATMS RESPECTIVELY. ANGIOPLASTY ALONE WAS UNABLE TO DILATE THE VESSEL; THEREFORE, A 6.0X60 NON-BSC STENT WAS IMPLANTED. POST DILATION WAS PERFORMED WITH INFLATION OF THE 6.0X40/135 (4F) STERLING MR BALLOON CATHETER TWO TIMES TO 14ATMS. DURING THE SECOND INFLATION A BALLOON RUPTURE OCCURRED AT 14ATMS. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT 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 13501226

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT, SMART 6X60| GUIDE WIRE, TREASURE XS| INTRODUCER SHEATH, 6F DESTINATION| BALLOON CATHETER, SHIDEN 3.0X40| GUIDE WIRE, JOURNEY 014-300| BALLOON CATHETER, SPCB 4MM