BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON®

    MDR report key: 3894880 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03686
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. INITIAL EXAMINATION OF THE DEVICE CONFIRMED THE BALLOON HAD DETACHED FROM THE CATHETER. THE CUTTING BALLOON CATHETER WAS RETURNED WITH A 0.0135 INCH GUIDEWIRE INSERTED THROUGH THE GUIDEWIRE LUMEN. THE CATHETER MOVED FREELY OVER THE GUIDEWIRE. THE BALLOON WAS RETURNED SEPARATE TO THE DELIVERY SYSTEM AND WAS SEVERELY DAMAGED. A MICROSCOPIC EXAMINATION OF THE DETACHED BALLOON IDENTIFIED A PARTIAL BLADE DETACH AND BLADE KINKS. THIS DAMAGE CAN POTENTIALLY BE A RESULT OF THE RESISTANCE ENCOUNTERED UPON ATTEMPTED REMOVAL FROM THE PATIENT. UPON EXAMINATION OF THE PROXIMAL BALLOON BOND, THE PROXIMAL MARKER BAND WAS IDENTIFIED IN THE BOND AREA WHICH WAS A RESULT OF THE INNER CATHETER DETACHING AND WHEN PULLED PROXIMALLY THROUGH THE BALLOON, THE MARKERBAND BECAME STUCK AT THE PROXIMAL BOND. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 4MM X 1.5MM X 140CM SMALL PERIPHERAL CUTTING BALLOON WAS ADVANCED AND INFLATION WAS PERFORMED. DURING WITHDRAWAL, THE DEVICE BECAME STUCK IN THE PATIENT. USING A SNARE, THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 4MM X 1.5MM X 140CM SMALL PERIPHERAL CUTTING BALLOON WAS ADVANCED AND INFLATION WAS PERFORMED. DURING WITHDRAWAL, THE DEVICE BECAME STUCK IN THE PATIENT. USING A SNARE, THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370181 SMALL PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001PCBO4015140F0 0016350146

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention