BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON¿

    MDR report key: 3013436 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01611
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    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

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK AT THE EXCHANGE PORT. A MICROSCOPIC EXAMINATION OF THE BREAK SITE FOUND THAT THE EXTRUSION WAS STRETCHED. FURTHER EXAMINATIONS OF THE RETURNED DEVICE CONFIRMED A KINK IN THE HYPOTUBE AT 6.5CM DISTAL TO THE STRAIN RELIEF. AN EXAMINATION OF THE BALLOON AND BLADES IDENTIFIED NO ISSUES. 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).

    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 PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, SHAFT SEPARATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. DURING PREPARATION, THE SHAFT OF THE 3.50MM X 1.5CM X 140CM SMALL PERIPHERAL CUTTING BALLOON FLEXTOME MONORAIL SEPARATED WHEN THE BALLOON PROTECTOR WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, SHAFT SEPARATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. DURING PREPARATION, THE SHAFT OF THE 3.50MM X 1.5CM X 140CM SMALL PERIPHERAL CUTTING BALLOON FLEXTOME MONORAIL SEPARATED WHEN THE BALLOON PROTECTOR WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116578 SMALL PERIPHERAL CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM3515140F0 15387074

    Patients

    Seq Age Sex Outcome Treatment
    1