BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 2000416 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00570
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: 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 DURING A PERCUTANEOUS PERIPHERAL TREATMENT PROCEDURE, THE BLADE LIFTED. THE LESION WAS LOCATED WITHIN AN ARTERIOVENOUS (AV) FISTULA. UPON COMPLETION OF THE AV FISTULA DILATATION, WHEN THE PHYSICIAN WENT TO WITHDRAW THE 8.0MM/2.0CM/90CM OVER-THE-WIRE PCB BALLOON CATHETER, AN ATHEROTOME LIFTED FROM THE BALLOON. IT WAS ALSO NOTICED THAT THE INTRODUCER SHEATH HAD BECOME DAMAGED FROM THE REMOVAL OF THE BALLOON WITH THE LIFTED ATHEROTOME. BLEEDING WAS NOTICED AROUND THE INTRODUCER SHEATH, BUT IT WAS ABLE TO BE CONTAINED WITH MANUAL PRESSURE TO THE ACCESS SITE. THE PATIENT'S STATUS WAS OKAY UPON PROCEDURE COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB8020900 13659103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other