BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2CM PERIPHERAL CUTTING BALLOON?

    MDR report key: 3213782 · Received July 9, 2013

    Report

    Report Number
    2134265-2013-04694
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Adverse Event
    Yes
    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)(4). DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 PROCEDURE, THE BLADE OF THE CUTTING BALLOON WAS LIFTED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS FOREARM SHUNT. A 6.00MM / 2.0CM / 90CM PERIPHERAL CUTTING BALLOON OTW WAS SELECTED TO ADVANCE AND TREAT THE TARGET LESION. AFTER SECOND DILATATION THE DEVICE WAS REMOVED FROM THE SHEATH. SEVERE RESISTANCE WAS ENCOUNTERED AND THE DEVICE COULD NOT BE REMOVED. THEREFORE, THE DEVICE HAD TO BE ADVANCED TO THE DISTAL PORTION AND A SECOND SHEATH WAS NEEDED TO FACILITATE THE REMOVAL OF THE DEVICE. THE SECOND SHEATH WAS INSERTED IN AN OPPOSITE DIRECTION FROM THE FIRST ONE. THE DEVICE WAS THEN ADVANCED INTO THE SECOND SHEATH. THE BALLOON THAT CAME OUT FROM THE HUB OF THE SECOND SHEATH WAS CUT WITH FORCEPS. THERE WAS NO DETACHMENT NOTED; HOWEVER, HALF OF ONE OF THE BLADES WAS FOUND TO BE LIFTED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312483 2CM PERIPHERAL CUTTING BALLOON? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001BP90620B0 15676136

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention