BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1833923 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04112
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    June 28, 2010
    Report Date
    August 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED EVIDENCE OF BALLOON INFLATION. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND AN ATTEMPT WAS MADE TO INFLATE THE DEVICE TO ITS RATED BURST PRESSURE (RBP) AND A LEAK WAS NOTED. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL REVEALED A PINHOLE LEAK 10MM DISTAL FROM THE PROXIMAL END OF THE BLADES. IN ADDITION, AN INDENTATION MARK WAS NOTED AT THE LEAK AREA. ONE ATHERECTOMY BLADE AND PAD HAD LIFTED 10MM IN LENGTH FROM THE PROXIMAL END OF THE BALLOON; HOWEVER, THE PROXIMAL TIP OF THE PAD REMAINED BONDED TO THE BALLOON. NO OTHER DAMAGE WAS NOTED ON THE DEVICE. THE BALLOON LEAK MAY HAVE PREVENTED COMPLETE BALLOON REFOLD, WHICH COULD CAUSE THE BLADE TO BECOME CAUGHT ON WITHDRAWAL AND LIFT THE BLADE FROM THE BALLOON. 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

    EVENT WAS DETERMINED TO BE REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A CUTTING BALLOON RUPTURE OCCURRED. THE DE NOVO LESION WAS LOCATED IN THE FISTULA. THE 7.00MM X 2.0CM PERIPHERAL CUTTING BALLOON WAS ADVANCED TO THE LESION FOR TREATMENT AND UPON ATTEMPTING TO INFLATE THE CUTTING BALLOON, THE BALLOON RUPTURED BELOW NOMINAL PRESSURE ON THE FIRST INFLATION. THE CUTTING BALLOON WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. RETURNED DEVICE ANALYSIS REVEALED A PARTIALLY DETACHED ATHERECTOMY BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB7020900 13383077

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK'S INFLATION DEVICE