BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3212864 · Received July 9, 2013

    Report

    Report Number
    2134265-2013-04691
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 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: A VISUAL EXAMINATION OF THE RETURNED UNIT CONFIRMED A SHAFT DETACHMENT AT 25.3CM FROM THE CATHETER TIP. STRETCHING WAS PRESENT FROM 24.5CM TO 24.9CM FROM THE CATHETER TIP. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE APPLIED TO THE DEVICE DURING ATTEMPTS TO REMOVE THE BALLOON PROTECTOR. THE BALLOON PROTECTOR WAS RETURNED OVER THE BALLOON. IT WAS NOT POSSIBLE TO APPLY A VACUUM TO THE BALLOON AS THE SHAFT WAS BROKEN HOWEVER DURING RETURNED DEVICE ANALYSIS THE BALLOON PROTECTOR WAS REMOVED FROM THE BALLOON REQUIRING STRONG FORCE. A VISUAL AND MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE TIP, BALLOON, OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. .

    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 PERIPHERAL INTERVENTION, A SHAFT DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON FLEXTOME MONORAIL WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, STRAIGHT FORCE WAS APPLIED AND RESISTANCE WAS ENCOUNTERED UPON THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE RING. IT WAS THEN NOTED THAT A SHAFT DETACHMENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION, A SHAFT DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON FLEXTOME MONORAIL WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, STRAIGHT FORCE WAS APPLIED AND RESISTANCE WAS ENCOUNTERED UPON THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE RING. IT WAS THEN NOTED THAT A SHAFT DETACHMENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312597 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 15812347

    Patients

    Seq Age Sex Outcome Treatment
    1