BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

    MDR report key: 3000450 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01487
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K960501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: (B)(6) 2013. DEVICE EVALUATED BY MANUFACTURER: AS THE DEVICE HAS NOT BEEN RETURNED A TECHNICAL ANALYSIS 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 TREATMENT PROCEDURE THE BALLOON WAS SLOW TO DEFLATE. THE PHYSICIAN FELT THE DEFLATION SPEED WAS SLOW ON THE ULTRATHIN DIAMOND BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103301 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK463

    Patients

    Seq Age Sex Outcome Treatment
    1