BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2CM PERIPHERAL CUTTING BALLOON¿

    MDR report key: 2915671 · Received January 15, 2013

    Report

    Report Number
    2134265-2012-08381
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    October 4, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION CONFIRMED THAT ONE BLADE AND PAD WAS RAISED FROM THE BALLOON 1CM FROM THE PROXIMAL END OF THE BALLOON. NO SECTIONS HAD DETACHED. SHAFT KINKS WERE PRESENT 32.5-35.5CM INCLUSIVE FROM THE STRAIN RELIEF. THE RETURNED DEVICE WAS CONNECTED TO AN ENCORE INFLATION UNIT AND POSITIVE PRESSURE WAS APPLIED WHEN A LEAK WAS NOTED. A MICROSCOPIC EXAMINATION CONFIRMED A PINHOLE TEAR <1MM IN LENGTH FROM THE DISTAL END OF THE BLADE. A MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE REMAINING BLADES. ALL REMAINING BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. THERE WERE NO ISSUES WITH THE TIP. 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 PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, BLADE DEFORMED. THE 90% STENOSED WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS SHUNT. THE 5.00MM/2.0CM/50CM 2CM PERIPHERAL CUTTING BALLOON OTW WAS INFLATED TO 6ATM ON THE 1ST TO 4TH INFLATIONS AND THEN RUPTURED. THERE WAS NO RESISTANCE WHEN THE PHYSICIAN WITHDREW THE DEVICE INTO THE SHEATH. HOWEVER, IT WAS NOTED THAT A BLADE WAS DEFORMED BUT NOT DETACHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED A LIFTED BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22728 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001BP50520B0 0014258841

    Patients

    Seq Age Sex Outcome Treatment
    1