BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3243368 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-05084
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED UNIT CONFIRMED A SHAFT DETACHMENT AT 25.6CM FROM THE CATHETER TIP. STRETCHING WAS PRESENT AT THE BREAK SITE. THIS DAMAGE IS CONSISTENT WITH THE REPORTED DIFFICULTIES ENCOUNTERED DURING ATTEMPTED REMOVAL OF THE BALLOON PROTECTOR CAP. THE RETURNED DEVICE HAD THE BALLOON PROTECTOR ATTACHED 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 RESISTANCE ENCOUNTERED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A SHAFT SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. A 4.00MM X 1.5CM X 140 CM SMALL PERIPHERAL CUTTING BALLOON FLEXTOME MONORAIL WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE BALLOON PROTECTOR FROM THE BALLOON. IT WAS THEN NOTED THAT THE SHAFT OF THE DEVICE WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A SHAFT SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. A 4.00MM X 1.5CM X 140 CM SMALL PERIPHERAL CUTTING BALLOON FLEXTOME MONORAIL WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE BALLOON PROTECTOR FROM THE BALLOON. IT WAS THEN NOTED THAT THE SHAFT OF THE DEVICE WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343462 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 15788826

    Patients

    Seq Age Sex Outcome Treatment
    1