BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3230380 · Received July 16, 2013

    Report

    Report Number
    2134265-2013-05025
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 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 FOR ANALYSIS. THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A SHAFT BREAK LOCATED 24.9CM FROM THE CATHETER TIP. THE SHAFT WAS STRETCHED AT THE BREAK SITE. 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 THE BALLOON PROTECTOR WAS REMOVED FROM THE BALLOON WITH RESISTANCE ENCOUNTERED. NO OTHER DAMAGE WAS NOTED TO THE CATHETER. 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).

    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, THE SHAFT OF A CUTTING BALLOON WAS SEPARATED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 4 MM X 1.5 CM X 140 CM SPCB FLEXTOME MR CUTTING BALLOON WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION OF THE PROCEDURE, IT WAS NOTED THAT THE BALLOON PROTECTOR COULD NOT BE REMOVED. THE BALLOON PROTECTOR WAS THEN PULLED HARD TO ATTEMPT REMOVAL; HOWEVER, IT WAS NOTED THAT THE SHAFT SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION, THE SHAFT OF A CUTTING BALLOON WAS SEPARATED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 4 MM X 1.5 CM X 140 CM SPCB FLEXTOME MR CUTTING BALLOON WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION OF THE PROCEDURE, IT WAS NOTED THAT THE BALLOON PROTECTOR COULD NOT BE REMOVED. THE BALLOON PROTECTOR WAS THEN PULLED HARD TO ATTEMPT REMOVAL; HOWEVER, IT WAS NOTED THAT THE SHAFT SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327935 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 15778169

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: DESTINATION| INFLATION DEVICE: EVEREST| GUIDEWIRE: CRUISE