BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1590133 · Received January 29, 2010

    Report

    Report Number
    2134265-2009-04153
    Event Type
    Injury
    Date Received
    January 29, 2010
    Date of Event
    July 21, 2005
    Report Date
    July 21, 2005
    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 IS CONSIDERED ANTICIPATED PROCEDURAL COMPLICATION, AS THIS COMPLAINT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B) (4). "PRODUCT UNAVAILABLE FOR ANALYSIS."

    Description of Event or Problem · 1

    (B) (6) PERIPHERAL CUTTING BALLOON REGISTRY. THE PATIENT UNDERWENT TREATMENT WITH THE PERIPHERAL CUTTING BALLOON IN (B) (6) 2005 FOR ONE LESION. THE TARGET LESION WAS AT THE ARTERIOVENOUS FISTULAE (AVF) ¿VERY RIGID STENOSIS. THERE WAS NO VESSEL TORTUOSITY; LESION TYPE WAS DENOVO AND NO CALCIFICATION AT TARGET LESION. THE ANGIOGRAPHIC DATA FOR TARGET LESION SHOWED THE REFERENCE VESSEL DIAMETER 5 MM, LESION LENGTH 10.00 MM, PRE PROCEDURE 80 % STENOSIS, AND POST PROCEDURE 0% STENOSIS. LESION MORPHOLOGY SHOWED CONCENTRIC STENOSIS AND TIGHT STENOSIS LESION. (B) (6) 2005 FIRST MONTH FOLLOW UP AND (B) (6) 2005 THIRD MONTH FOLLOW UP - VITAL STATUS OF THE PATIENT WAS ¿ALIVE¿, WITH VERY GOOD PATENCY. THE TARGET LESION HAS REMAINED PATENT SINCE THE PROCEDURE. THE PATIENT HAD NO ADVERSE EVENT, NOR HAS THE PATIENT REQUIRED ANY INTERVENTIONS SINCE PROCEDURE. IN (B) (6) 2005, 6 MONTHS FOLLOW UP ¿ PATIENT STATUS WAS ¿ALIVE¿, THE COMMENTS NOTED ¿RESTENOSIS¿. THE TARGET LESION HAS REMAINED PATENT AND THE PATIENT HAS NOT EXPERIENCE ANY ADVERSE EVENT SINCE THE PROCEDURE. DURING THE FOLLOW UP VISIT THE PATIENT HAD AN INTERVENTION. THE PATIENT HAD CONVENTIONAL ANGIOPLASTY ON THE TARGET LESION DUE TO ANGIOGRAPHIC RESTENOSIS. IN (B) (6) 2006, 12 MONTH FOLLOW-UP ¿ PATIENT VITAL STATUS ¿ALIVE¿. THE TARGET LESION HAS REMAINED PATENT AND THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EVENTS AND NO OTHER INTERVENTIONS SINCE THE PROCEDURE.

    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 74 YR Required Intervention