BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP

    MDR report key: 3032434 · Received March 29, 2013

    Report

    Report Number
    2182269-2013-00016
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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) STATES THAT 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 DEVICE INSTRUCTION FOR USE (IFU) STATES TO NOT USE THE ANGIO-SEAL DEVICE WHERE BACTERIAL CONTAMINATION OF THE PROCEDURE SHEATH OR SURROUNDING TISSUES MAY HAVE OCCURRED AS THIS MAY RESULT IN AN INFECTION. 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 TISSUE 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

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. THE PT WAS READMITTED TO THE HOSPITAL 2 WEEKS AFTER ANGIO-SEAL DEPLOYMENT WITH A (B)(6) INFECTION. REDNESS AND IRRITATION WERE NOTED AT THE DEPLOYMENT SITE AND AN INFLAMED GROIN. THE PT RECEIVED DOUBLE ANTIBIOTICS FOR 4 DAYS. AN ULTRASOUND WAS PERFORMED TO ASSESS THE GROIN PUNCTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131045 6F ANGIO-SEAL VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R