BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-SOFT? SV

    MDR report key: 3232804 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04866
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K050389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: 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 TRANSLUMINAL ANGIOPLASTY PROCEDURE, THE BALLOON CATHETER FROZE ON THE WIRE. VASCULAR ACCESS WAS OBTAINED VIA RIGHT BRACHIAL ARTERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT RENAL ARTERY. A 153CM, 1.5MM X 7.0MM ULTRA-SOFT SV BALLOON CATHETER WAS USED FOR DILATATION. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, AN UNSPECIFIED GUIDE WIRE BECAME STUCK INSIDE THE BALLOON. THE BALLOON WAS REMOVED "NORMALLY". THE PROCEDURE WAS COMPLETED WITH A 7×20 MR STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334267 ULTRA-SOFT? SV CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H7493791670150 14738802

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: JNJ BRITETIP JR6FR 110CM