BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 555951 · Received November 19, 2004

    Report

    Report Number
    2182269-2004-00201
    Event Type
    Injury
    Date Received
    November 19, 2004
    Date of Event
    October 29, 2004
    Report Date
    November 19, 2004
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A DIAGNOSTIC CORONARY ANGIOGRAM AND CORONARY INTERVENTION OF THE CIRCUMFLEX OBTUSE MARGINAL 1(OM 1) AND OBTUSE MARGINAL 3(OM 3) VESSELS, AN ANGIO-SEAL DEVICE WAS DEPLOYED IN THE RIGHT FEMORAL ARTERIOTOMY SITE. APPROX TWENTY MINUTES LATER, THE PT DEVELOPED ACUTE RIGHT LEG ISCHEMIA. A RIGHT FEMORAL ANGIOGRAM AND VESSEL RUN-OFF STUDY WAS DONE VIA THE LEFT COMMON FEMORAL ARTERY, REVEALED AN OCCLUSIVE DISSECTION OF THE RIGHT COMMON FEMORAL ARTERY. THROUGH THE LEFT FEMORAL ARTERY, A 6F BALKIN UP AND OVER SHEATH WAS PLACED; A STENT WAS PLACED IN THE RIGHT COMMON FEMORAL ARTERY RESULTING IN BOUNDING PEDAL PULSES. THE SHEATH WAS SUTURED IN PLACE AND THE PT LEFT THE LAB. THE PT WAS INSTRUCTED TO FOLLOW UP IN ONE WEEK. MEDICATION DURING THE PROCEDURES WERE: D5NORMAL SALINE 75 CC PER HOUR IV (INTRAVENOUS), LIDOCAINE 1% LOCAL 20 CC SQ (SUBCUTANEOUS), ANGIOMAX BOLUS 10.5 XX IV, ANGIOMAX DRIP, 25 CC PER HOUR IV X 46 MINUTES, NITROGLYCERIN 400 MCG IC (INTRACORONARY), ANCEF 1 GRAM IV, OMNIPAQUE CONTRAST 325 CC FOR CORONARY PROCEDURES, VISIPAQUE CONTRAST 180 CC FOR FEMORAL PROCEDURES. IT IS UNK IF A PRE-INSERTION ANGIOGRAM WAS DONE, FIVE RADIOGRAPHIC PAPER PRINT IMAGES WERE SENT WITH THE INCIDENT. THESE IMAGES WERE TAKEN IN A FRONTAL PROJECTIONS AND THE FIRST RADIOGRAPHIC IMAGE, REVEALED AN OCCLUSIVE RIGHT FEMORAL ARTERY. THIS IMAGE WAS MARKED A AT THE POINT OF OCCLUSION AND DESCRIBED AS THE DISSECTED SITE. THE SECOND IMAGE REVEALED GOOD BLOODFLOW IN THE SAME AREA; DISTAL TO THE A THERE IS A B DESCRIBED AS THE ARTERIOTOMY AND DISTAL TO THAT, BUT PROXIMAL TO THE BIFURCATION OF THE FEMORAL PROFUNDA AND SUPERFICAL FEMORAL ARTERY THERE IS A C DESCRIBED AS "COLLAGEN CONSTRUCT." THE FINAL IMAGES ARE SIMILAR WITH THE EXCEPTION OF THE COLLAGEN WHICH IS LOCATED AT THE BIFURCATION. EXCELLENT BLOOD FLOW WAS RESTORED. A SEARCH OF THE DATABASE DID NOT REVEAL CERTIFICATION DOCUMENTATION FOR THIS USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 8F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention