BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON¿

    MDR report key: 2883395 · Received December 21, 2012

    Report

    Report Number
    2134265-2012-07788
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    August 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    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) THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE SHAFT. THE SHAFT WAS BROKEN 25CM FROM THE CATHETER TIP AT THE EXCHANGE PORT AREA. THE BALLOON PROTECTOR WAS RETURNED ON THE BALLOON, AND THE BALLOON SHOWED NO SIGNS OF USE. THE BALLOON PROTECTOR WAS REMOVED FROM THE BALLOON. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON. THE TIP WAS MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE. NO FURTHER DAMAGE WAS NOTED TO THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON PRODUCT ANALYSIS COMPLETED (B)(4) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED RIGHT POPLITEAL ARTERY. THE PHYSICIAN ADVANCED A 4.00MM X 1.5CM X 140CM SPCB FLEXTOME MR CUTTING BALLOON TO THE LESION AND ON THE 1ST INFLATION AT 6ATMS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD. RETURNED PRODUCT ANALYSIS REVEALED A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL PERIPHERAL CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 15325017

    Patients

    Seq Age Sex Outcome Treatment
    1