BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 1790121 · Received August 5, 2010

    Report

    Report Number
    2182269-2010-00143
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    August 13, 2009
    Report Date
    August 5, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES POTENTIAL ADVERSE REACTIONS OR CONDITIONS MAY BE ASSOCIATED WITH ONE OR MORE ANGIO-SEAL DEVICE COMPONENTS (I.E., COLLAGEN, SYNTHETIC ABSORBABLE SUTURE, AND/OR POLYMER). THESE INCLUDE ALLERGIC REACTION, FOREIGN BODY REACTION, POTENTIATION OF INFECTION, INFLAMMATION AND EDEMA. THE ANGIO-SEAL PATIENT INFORMATION GUIDE STATES SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, THE PATIENT SHOULD CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THE PATIENT INFORMATION CARD IF THEY EXPERIENCE FEVER, BLEEDING, PERSISTENT SWELLING IN THE GROIN OR SWELLING, REDNESS AND/OR WARM TO TOUCH, NUMBNESS TINGLING OR PAIN IN THE EXTREMITY WHEN AMBULATING, RASH, WOUND DRAINAGE OR ANY OTHER UNUSUAL SYMPTOMS.

    Description of Event or Problem · 1

    ACCORDING TO THE PATIENT, FOLLOWING A CARDIAC CATHETERIZATION AN ANGIO-SEAL WAS USED AND AN UNKNOWN ISSUE OCCURRED. ALLEGEDLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION AND THE ANGIO-SEAL WAS REMOVED FROM THE FEMORAL ARTERY. THE PATIENT STATED THAT HER HOSPITALIZATION WAS EXTENDED DUE TO THIS EVENT AND SHE REPORTS THAT SHE CONTINUES TO HAVE DISCOMFORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R