BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIS SVG/FLOW CONTROL, 7F LONG SHEATH

    MDR report key: 1095334 · Received July 31, 2008

    Report

    Report Number
    3004028841-2008-00001
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NFA
    PMA / PMN Number
    KO6O651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO 7F PROXIS LONG SHEATH ASSEMBLIES AND INFLATION DEVICES WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED. EACH SHEATH HAD MULTIPLE AREAS OF KINKED/PARTIALLY CRUSHED SHEATH TUBING WITH CORRESPONDING INFLATION LUMEN DAMAGE. DEVICE 1: THE BALLOON REMAINED PARTIALLY INFLATED UPON RECEIPT. THERE WAS NO VISIBLE INDICATION OF BALLOON RUPTURE, OR OF A BLOOD-LIKE SUBSTANCE (BLS) WITHIN THE BALLOON OR ANY OTHER PORTION OF THE INFLATION SYSTEM. THE DEVICE WAS FUNCTIONALLY TESTED; NO FUNCTIONAL ANOMALIES WERE NOTED. DEVICE 2: THE DEVICE WAS FUNCTIONALLY TESTED. OVERALL DEVICE OPERATION WAS CONSISTENT WITH A PARTIAL OBSTRUCTION IN THE SHEATH DEFLATION PATH RESULTING FROM THE SHEATH TUBING BEING KINKED AND/OR PARTIALLY CRUSHED. ONE OF THE 2 TABS ON THE GAS FILTER LUER-LOCK FITTING HAD BEEN DETACHED; THE TAB WAS INSIDE THE MATING LUER-LOCK FITTING OF THE INFLATION DEVICE STOPCOCK. REVIEW OF THE DEVICE HISTORY RECORDS FOR LOTS 2052064 (MFG DATE 11/29/2007, USE BY DATE 10/2008) AND 2059385 (MFG DATE 12/27/2007, USE BY DATE 11/2008) CONFIRMED THESE LOTS MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENTS. THE PROXIS EMBOLIC PROTECTION SYSTEM INSTRUCTIONS FOR USE (IFU) STATES A 4.5 MM DIAMETER BALLOON OR STENT DELIVERY SYSTEM ARE THE LARGEST SIZES RECOMMENDED FOR USE WITH THE 7F PROXIS SYSTEM. THE PROXIS DEVICE INSTRUCTIONS FOR USE (IFU) STATE THE PROXIS SYSTEM SHOULD BE CAREFULLY MANIPULATED ONLY WHILE UNDER FLUOROSCOPIC OBSERVATION THAT PROVIDES HIGH-RESOLUTION IMAGES SO AS TO REDUCE VESSEL INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A BYPASS CORONARY GRAFT ANGIOGRAM AND DIAGONAL GRAFT INTERVENTION THAT 3 7F PROXIS SVG/FLOW CONTROL LONG SHEATH DEVICES WERE OPENED FOR USE. WITH THE FIRST PROXIS USED FROM LOT 2059385, THE BALLOON RUPTURED DURING INFLATION, BUT NO DAMPENING IN PT PRESSURE OCCURRED. THE CO2 INFUSED INTO THE PT WITH NO ADVERSE REACTION. THIS DEVICE WAS REMOVED AND THE BALLOON WAS CHECKED. BLOOD WAS SEEN IN THE BALLOON AND THE BALLOON WOULD NOT INFLATE. A SECOND PROXIS DEVICE FROM LOT 2052064 WAS OPENED BUT NEVER INSERTED INTO THE PT. AFTER PREPPING THE PROXIS, THE BALLOON CONTINUED TO INFLATE ON IT'S OWN. ONCE THE DEFLATION BUTTON WAS PRESSED, THE INFLATION WOULD CONTINUE ON IT'S OWN FILLING THE BALLOON AND THE GREEN INDICATOR WOULD FILL. A THIRD PROXIS DEVICE FROM LOT 2052064 WORKED WITHOUT EVENT. THE PT DID HAVE A SMALL DISSECTION IN DISTAL SEGMENT OF DIAGONAL GRAFT AT THE END OF CASE. THE PROXIS WAS NEVER PLACED INTO THE DISTAL VESSEL AND THE DISSECTION WAS DUE TO THE GUIDEWIRE PER DR (B)(6). THE PT LEFT THE CATH LAB WITHIN NORMAL LIMITS PER STAFF. A 7F MEDTRONIC GUIDING CATHETER, A 7F ULTIMUM ACT INTRODUCER SHEATH AND A 4.5 X 40 MULTILINK STENT WERE USED DURING THE PROCEDURE. THE PHYSICIAN WAS IN THE PROXIS TRAINING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIS SVG/FLOW CONTROL, 7F LONG SHEATH PROXIS NFA ST. JUDE MEDICAL NA 2059385

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other