BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVVY LONG PTA DILATATION CATHETER

    MDR report key: 2842134 · Received November 21, 2012

    Report

    Report Number
    1016427-2012-20005
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PTA (STENTING) SLIGHT DISSECTION WAS CONFIRMED NEAR THE MID PORTION OF THE SUPERFICIAL FEMORAL ARTERY AND THE BALLOON RUPTURED BELOW NOMINAL PRESSURE. IT IS UNKNOWN IF THE LESION WAS A DE NOVO, BUT IT WAS MODERATELY CALCIFIED, AND SLIGHTLY TORTUOUS THROUGHOUT THE SFA. THERE WAS 80% STENOSIS AT THE LESION. IPSILATERAL ANTEROGRADE APPROACH WAS MADE FROM THE SUPERFICIAL FEMORAL ARTERY WITH A SHEATH INTRODUCER (MEDIKIT'S 6F 11 CM). THE LESION WAS CROSSED WITH A GUIDE WIRE (CHEVALIER) WITHOUT ANY DIFFICULTY. SAVVY LONG (5/120 MM 80 CM: COMPLAINT PRODUCT) WAS DELIVERED TO THE LESION, AND THE BALLOON WAS INFLATED SEVERAL TIMES AT THE LESION. DURING THE SEVERAL DILATIONS, THE BALLOON WAS INFLATED SLOWLY AT LOW PRESSURE FOR A LONG TIME AT EACH DILATION, BUT SLIGHT DISSECTION WAS CONFIRMED NEAR THE MID PORTION OF THE SUPERFICIAL FEMORAL ARTERY, AND THE BALLOON RUPTURED BELOW THE NOMINAL PRESSURE. A SMART CONTROL (6X100 MM) WAS DELIVERED FOR TREATMENT OF THE DISSECTION AND POST DILATION WAS CONDUCTED WITH A DIFFERENT BALLOON CATHETER (AVIATOR PLUS 5/40 MM). THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THE DISSECTION GRADE WAS UNKNOWN, BUT IT WAS NOT FLOW LIMITING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON AND THE CATHETER EVER IN AN ACUTE BEND. THE MAXIMUM INFLATION PRESSURE WAS 6 ATM. THE BALLOON DID NOT KINK WHILE BEING USED AND WAS EASILY REMOVED. IT WAS INTACT UPON REMOVAL.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT A PATIENT EXPERIENCED A SLIGHT DISSECTION AND A 5MM X 120MM SAVVY LONG BALLOON RUPTURED DURING THE PROCEDURE. THE LOT HISTORY REVIEW DID NOT PRESENT ANY ANOMALIES. WITHOUT THE RETURN OF THE DEVICE THE REPORTED CUSTOMER COMPLAINT OF BALLOON BURST COULD NOT BE CONFIRMED. ARTERIAL DISSECTIONS ARE A KNOWN ADVERSE EVENT ASSOCIATED WITH ANGIOPLASTY PROCEDURES. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT LESION CHARACTERISTICS AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NOTHING IN THE DEVICE HISTORY REPORT REVIEW OR THE EVENT DESCRIPTION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY LONG PTA DILATATION CATHETER PTA CATHETERS LIT CLEARSTREAM TECHNOLOGIES LTD NA 50036125

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R DESCRIBED IN EVENT.