BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1790104 · Received August 5, 2010

    Report

    Report Number
    2182269-2010-00141
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    July 24, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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

    IT WAS REPORTED THAT A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE AND DEPLOYED WITH NO COMPLICATION PRESENT DURING DEPLOYMENT. THE HOSPITAL STAY PRIOR TO DISCHARGE WAS ALSO FREE OF COMPLICATIONS. FIVE DAYS LATER, THE PATIENT EXPERIENCED GROIN PAIN WHILE DRIVING. THE PATIENT RETURNED TO THE HOSPITAL WHERE AN ULTRASOUND ASSESSMENT REVEALED A PROBABLE DISSECTION WITH GOOD DISTAL FLOW. NO TREATMENT WAS REQUIRED AND THE PATIENT WAS SENT HOME IN STABLE CONDITION. THE PATIENT WAS REPORTED TO BE OBESE. THE PHYSICIAN ALLEGES THAT THE ANGIO-SEAL MIGHT HAVE CAUSED THE INCIDENT. THERE WAS NO OTHER INFORMATION AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention