BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3931594 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-03943
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    March 28, 2014
    Report Date
    June 16, 2014
    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 AND OLDER. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BREAK AT THE EXCHANGE PORT AREA APPROXIMATELY 25CM FROM THE TIP. THE BALLOON PROTECTOR CAP WAS RETURNED POSITIONED OVER THE DISTAL HALF OF THE BALLOON. THE BALLOON PROTECTOR WAS REMOVED FROM THE REMAINING SECTION OF THE BALLOON WITH NO ISSUES NOTED. NO FURTHER DAMAGE WAS NOTED. 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 WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON PRODUCT ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT REMOVAL DIFFICULTY OF THE BALLOON PROTECTOR OCCURRED. THE MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON FLEXTOME MONORAIL WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, THE DEVICE WAS TAKEN OUT OF THE HOOP AND THE USER DRAW BACK ON THE SYRINGE TO ITS FULL VOLUME DEFLATING THE BALLOON, AND REMOVE ALL AIR FROM THE BALLOON PRIOR TO BALLOON PROTECTOR REMOVAL. UPON REMOVAL OF THE BALLOON PROTECTOR, RESISTANCE WAS ENCOUNTERED AND THEY PULLED IT FORCIBLY, IT GOT DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409441 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 16618238

    Patients

    Seq Age Sex Outcome Treatment
    1