BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN¿ DIAMOND¿

    MDR report key: 3011238 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01484
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 18, 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

    DEVICE EVALUATED BY MANUFACTURER: THERE IS NO ISSUE WITH THE DEVICE. THE DEVICE WAS INFLATED TO 15ATMS AND A VACUUM PULLED. THE BALLOON DEFLATED WITHIN SPECIFICATION. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (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 90% STENOSED LESION WAS LOCATED IN A SHUNT IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS LEFT UPPER ARM. THE PHYSICIAN FELT THE DEFLATION SPEED WAS SLOW ON THE ULTRATHIN DIAMOND DT/6-4/5/40 BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE THE BALLOON WAS SLOW TO DEFLATE. THE 90% STENOSED LESION WAS LOCATED IN A SHUNT IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS LEFT UPPER ARM. THE PHYSICIAN FELT THE DEFLATION SPEED WAS SLOW ON THE ULTRATHIN DIAMOND DT/6-4/5/40 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
    113791 ULTRA-THIN¿ DIAMOND¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001164620 0015700044

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: 035KYOUSHA| INFLATION DEVICE: EVEREST