BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2083609 · Received May 10, 2011

    Report

    Report Number
    2134265-2011-01734
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 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: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLY 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 TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT COMMON FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION WAS IN-STENT RESTENOSIS OF ANOTHER MANUFACTURER¿S 6.0X40MM STENT WHICH WAS IMPLANTED ONE YEAR AGO. THE STERLING MR 4.5X20/135 (4F) BALLOON DILATATION CATHETER WAS ADVANCED WITH MILD RESISTANCE WHEN THE BALLOON CROSSED THE LESION. THE BALLOON RUPTURED AT 12ATMS UPON THE THIRD INFLATION (FIRST INFLATION WAS AT 8ATMS FOR APPROXIMATELY 60 SECONDS AND THE SECOND INFLATION WAS AT 10ATMS FOR APPROXIMATELY 60 SECONDS). THE BALLOON WAS USED FOR PRE-DILATATION AND THE PROCEDURE WAS COMPLETED WITH AN SPCB CUTTING BALLOON DILATATION CATHETER. 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 H74939031452010 12889909

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: LUMINEXX 6.0X40MM| INFLATION DEVICE: ENCORE26| GUIDING INTRODUCER: 6FR MEDIKIT| GUIDEWIRE: TRESURE