BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME® CUTTING BALLOON®

    MDR report key: 2991468 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01254
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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. NO KINKS OR DAMAGE WERE NOTED ALONG THE SHAFT OF THE DEVICE. A GUIDEWIRE WAS INSERTED INTO THE CATHETER TIP WITH NO ISSUES. THE GUIDEWIRE AND CATHETER WERE ADVANCED THROUGH A SUPER SHEATH WITH NO ISSUES. THE CATHETER EXITED THE SHEATH SUCCESSFULLY. 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 CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PCI), A LIFTED BLADE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHILE INTRODUCING THE 06/4.00 FLEXTOME CUTTING BALLOON, THE BALLOON HUNG UP ON THE TOUHY VALVE. THE DEVICE WAS EXAMINED AND THE BLADE WAS LIFTED OFF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PCI), A LIFTED BLADE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHILE INTRODUCING THE 06/4.00 FLEXTOME CUTTING BALLOON, THE BALLOON HUNG UP ON THE TUOHY VALVE. THE DEVICE WAS EXAMINED AND THE BLADE WAS LIFTED OFF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96037 FLEXTOME® CUTTING BALLOON® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749CBM3400060 0015245976

    Patients

    Seq Age Sex Outcome Treatment
    1