BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1790105 · Received August 5, 2010

    Report

    Report Number
    2182269-2010-00144
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    May 1, 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
    UK
    Reporter Occupation
    PHYSICIAN

    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 THAT BLEEDING OR HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE IFU STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL PATIENT INFORMATION GUIDE STATE 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 AN EMERGENCY ANGIOPLASTY WAS PERFORMED AND POST PROCEDURE, A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. THE PATIENT WAS GIVEN REOPRO, CLOPIDOGREL AND ASPIRIN DURING THE PROCEDURE. A PRE-INSERTION ANGIOGRAM WAS PERFORMED AND AN ANGIO-SEAL VIP DEVICE WAS DEPLOYED SUCCESSFULLY WITH HEMOSTASIS ACHIEVED AND THE PATIENT WAS RECOVERED TO THE WARD. THE PATIENT DEVELOPED A HEMATOMA POST PROCEDURE AND AN ULTRASOUND CONCLUDED THAT THE HEMATOMA WAS STABLE WITH NO RISK OF EMBOLIZATION, OCCLUSION OR PSEUDOANEURYSM FORMATION. THE PATIENT WAS DISCHARGED. IN (B)(6) 2010, THE PATIENT WAS ADMITTED WITH SYMPTOMS OF CLAUDICATION IN THE RIGHT LEG. IT IS UNKNOWN IF THERE WAS A DIAGNOSTIC ANGIOGRAM PERFORMED AT THIS TIME, BUT THE PATIENT UNDERWENT SURGICAL INTERVENTION. THE VASCULAR CONSULTANT FROM THE HOSPITAL REMOVED A "10CM DEVICE" FROM THE PATIENT'S LEG INFORMING THE PATIENT THAT IT WAS AN ALLEGED ANGIO-SEAL. THE DEPLOYING PHYSICIAN DOES NOT THINK THE INCIDENT IS ANGIO-SEAL RELATED AND HAS REFUSED TO COMMENT WITHOUT FURTHER INFORMATION. THE DEVICE REMOVED FROM THE PATIENT WAS NOT KEPT. THE EVENT, IMPLANT, AND EXPLANT DATES ARE MONTH SPECIFIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R