BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1590165 · Received January 29, 2010

    Report

    Report Number
    2134265-2009-04300
    Event Type
    Injury
    Date Received
    January 29, 2010
    Date of Event
    December 6, 2005
    Report Date
    February 2, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-LETTERKENNY
    Product Code
    LIT
    PMA / PMN Number
    K040155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE, A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATIONS. THIS COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE.(B) (4): "PRODUCT UNAVAILABLE FOR ANALYSIS."

    Description of Event or Problem · 1

    (B) (4) PERIPHERAL CUTTING BALLOON REGISTRY.IN (B) (6) 2005, A CONCENTRIC, TIGHT, RESTENOTIC POST PTA LESION WAS IDENTIFIED IN AN AVF. THE TARGET VESSEL WAS NON TORTUOUS WITHOUT CALCIFICATION AND HAD A REFERENCE DIAMETER WAS 7MM. THE TARGET LESION LENGTH WAS 15MM AND 80% STENOSED. THE PERIPHERAL CUTTING BALLOON WAS USED TO DILATE THE LESION. NUMBER OF INFLATIONS, TIME AND MAXIMUM INFLATION PRESSURE IS NOT PROVIDED IN THE CRF DATA. NO PAIN WAS PERCEIVED DURING THE PROCEDURE. TARGET LESION POST-PROCEDURE STENOSIS WAS 10%. PATIENT FOLLOW UPS IN (B) (6) 2005 REPORTED THE PATIENT'S STATUS ¿ALIVE¿. NO ADVERSE EVENTS OR ADDITIONAL INTERVENTIONS WERE REPORTED.6 MONTHS FOLLOW UP ASSESSMENT IN (B) (6) 2006, IT WAS RECORDED THAT THE PATIENT UNDERWENT CONVENTIONAL ANGIOPLASTY IN (B) (6) 2006 OF THE TARGET LESION DUE TO ANGIOGRAPHIC RESTENOSIS. PATIENT'S STATUS WAS ¿ALIVE¿ AND THE TARGET LESION WAS REPORTED PATENT. NO ADVERSE EVENTS WERE REPORTED. IN (B) (6) 2006 12 MONTH FOLLOW UP, PATIENT'S STATUS ¿ALIVE¿ WITHOUT ADVERSE EVENTS, TARGET LESION WAS PATENT AND NO ADDITIONAL INTERVENTIONS REPORTED. ¿OTHER¿ DIAGNOSTIC EXAMINATION WAS PERFORMED, RECORDED AS ¿CHECKING BP AND FLOW DURING DIALYSIS¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION-LETTERKENNY

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention