BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTOME¿ CUTTING BALLOON¿

    MDR report key: 2823222 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06805
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, BALLOON DEFLATION AND REMOVAL DIFFICULTIES OCCURRED. THE 60% RESTENOSED TARGET LESION WAS LOCATED IN A PREVIOUSLY IMPLANTED NON BSC STENT WITHIN A VEIN GRAFT OF THE MID RIGHT CORONARY ARTERY (RCA). THE 10/3.00 FLEXTOME CUTTING BALLOON WAS ADVANCED WITHIN THE STENT. INFLATION WAS PERFORMED TWICE TO 10 AND 11ATMS FOR 20 SECONDS. DIFFICULTY WAS NOTED DURING DEFLATION AND WITHDRAWAL, AS THE BALLOON HAD BECOME STUCK IN THE STENT. IN AN ATTEMPT TO REMOVE THE BALLOON, A SECOND GUIDE WIRE WAS ADVANCED. THE PARTIALLY DEFLATED BALLOON WAS ABLE TO BE REMOVED; HOWEVER, THE IMPLANTED STENT BECAME DISPLACED AND MIGRATED AS A RESULT. THE PROCEDURE WAS ENDED AFTER AN UNSPECIFIED STENT WAS IMPLANTED WITHIN THE PREVIOUSLY IMPLANTED NON BSC STENT WHICH WAS AT THE OSTIUM OF THE VEIN GRAFT. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. NO ADDITIONAL INTERVENTION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME¿ CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749RB4300100 15124726

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention