BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2CM PERIPHERAL CUTTING BALLOON®

    MDR report key: 3822487 · Received May 20, 2014

    Report

    Report Number
    2134265-2014-02770
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR EVALUATION. DEVICE ANALYSIS NOTED THAT APPROXIMATELY 1CM OF BLADE AND PAD HAD LIFTED FROM THE BALLOON'S PROXIMAL BODY. THE BLADE AND PAD WERE NOT DETACHED AND WERE RAISED DISTALLY. NO FURTHER DAMAGE WAS NOTED. 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 BLADE SEPARATED. A 5.00MM/2.0CM/90CM OTW 2CM PERIPHERAL CUTTING BALLOON® WAS SELECTED TO TREAT THE TARGET LESION. DURING THE PROCEDURE, WHILE THE DEVICE WAS INSIDE THE PATIENT, IT WAS NOTED THAT THE CUTTING BLADE SEPARATED FROM THE BALLOON; HOWEVER, IT WAS NOTED THAT THE BLADE DID NOT COME OFF ALL THE WAY. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE SEPARATED. A 5.00MM/2.0CM/90CM OTW 2CM PERIPHERAL CUTTING BALLOON® WAS SELECTED TO TREAT THE TARGET LESION. DURING THE PROCEDURE, WHILE THE DEVICE WAS INSIDE THE PATIENT, IT WAS NOTED THAT THE CUTTING BLADE SEPARATED FROM THE BALLOON; HOWEVER, IT WAS NOTED THAT THE BLADE DID NOT COME OFF ALL THE WAY. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300157 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB5020900 16630641

    Patients

    Seq Age Sex Outcome Treatment
    1