BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON®

    MDR report key: 3925640 · Received July 10, 2014

    Report

    Report Number
    2134265-2014-04022
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SHAFT BROKE AND SEPARATED. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WAS SELECTED TO TREAT THE TARGET LESION. DURING UNPACKING, THE DEVICE WAS PULLED OUT FROM THE PACKAGING. IT WAS THEN NOTED THAT THE CATHETER SHAFT BROKE AND SEPARATED. PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405191 SMALL PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001PCBM4015140F0 16449879

    Patients

    Seq Age Sex Outcome Treatment
    1