BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 2854206 · Received November 29, 2012

    Report

    Report Number
    2182269-2012-00132
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION THAT A PSEUDOANEURYSM IS A POSSIBLE RISK ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT THE ANGIO-SEAL KIT IS SUPPLIED STERILE IN A POLY BAG. THE BAG INCLUDES A SEALED TRAY CONTAINING THE ANGIO-SEAL COMPONENTS. THE ANGIO-SEAL IS LABELED STERILE. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER TO OBSERVE STERILE TECHNIQUE AT ALL TIMES WHEN USING THE DEVICE. THE USE OF THE DEVICE WHERE BACTERIAL CONTAMINATION OF THE PROCEDURE SHEATH OR SURROUNDING TISSUES MAY HAVE OCCURRED MAY CAUSE INFECTION. ANY SIGN OF INFECTION AT THE PUNCTURE SITE SHOULD BE TAKEN SERIOUSLY AND THE PT MONITORED CAREFULLY. SURGICAL REMOVAL OF THE DEVICE SHOULD BE CONSIDERED WHENEVER AN ACCESS SITE INFECTION IS SUSPECTED.

    Description of Event or Problem · 1

    THE FOLLOWING LITERATURE ARTICLE WAS PUBLISHED IN THE HINDAWI PUBLISHING CORPORATION CASE REPORTS IN VASCULAR MEDICINE, VOLUME 2012, ARTICLE 292945 WITH AN E-PUBLICATION ON 10/18/2012: A (B)(6) FEMALE PT WAS ADMITTED FOR EVAL OF STABLE ANGINA PECTORIS. AFTER CLINICAL EXAMINATION, ECHOCARDIOGRAPHY, AND CORONAROGRAPHY, INDICATION FOR ANGIOPLASTY OF THE RAMUS INTERVENTRICULARIS ANTERIOR WAS ESTABLISHED. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS SUCCESSFULLY PERFORMED, AND TWO CORONARY STENTS WERE DEPLOYED DURING THE PROCEDURE. ARTERIAL ACCESS WAS OBTAINED THROUGH THE RIGHT COMMON FEMORAL ARTERY, AND AN ANGIO-SEAL VASCULAR CLOSURE DEVICE WAS DEPLOYED AT THE CONCLUSION. THE NEXT DAY, THE PT WAS DISCHARGED IN GOOD CONDITION. THREE WEEKS AFTER THE DISCHARGE, THE PT WAS READMITTED DUE TO DEHYDRATION, POOR GENERAL CONDITION, AND FEVER (38 DEGREES CELSIUS). CLINICAL EXAMINATION REVEALED THE PRESENCE OF PULSATING MASS IN THE RIGHT GROIN OF 3 CM IN DIAMETER, AND A PUNCTIFORM WOUND IN THE CENTER WITH PURULENT DISCHARGE. ULTRASONOGRAPHY AND COMPUTED TOMOGRAPHY (CT) VERIFIED THE PRESENCE OF A PSEUDOANEURYSM OF THE RIGHT COMMON FEMORAL ARTERY (2.5 CM IN DIAMETER). AFTER CLAMPING AND RESECTION OF THE PSEUDOANEURYSM, TOTAL DESTRUCTION OF THE ANTERIOR WALL DUE TO AN INFECTION PROCESS OF THE COMMON FEMORAL ARTERY IN LENGTH OF 2 CM, WAS NOTED. THE WOUND WAS RECONSTRUCTED IN LAYERS WITHOUT CLOSING THE SKIN. FURTHER POSTOPERATIVE COURSE WAS UNEVENTFUL WITH NORMALIZATION OF LAB MARKERS OF INFLAMMATION. ANTIBIOTICS (UNK TYPE/DOSE/STRENGTH) WERE ADMINISTERED ACCORDING TO THE RESULTS OF AN INTRAOPERATIVELY OBTAINED WOUND SWAB. ON THE SEVENTH POSTOPERATIVE DAY, THE GROIN SKIN WAS SUTURED, THE FEW DAYS LATER, THE PT WAS DISCHARGED. DURING A SIX MONTH F/U PERIOD, THE PT WAS DOING WELL WITH HEALED WOUNDS AND A PEDOBRACHIAL INDEX OF 1.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R