BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1020337 · Received March 26, 2008

    Report

    Report Number
    2182269-2008-00106
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    April 28, 2007
    Report Date
    March 3, 2008
    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. 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. ONE SUTURE SEGMENT, CONSISTENT IN APPEARANCE WITH THAT USED IN THE ANGIO-SEAL DEVICE, WAS RECEIVED FOR EVAL. NO OTHER VISUALLY IDENTIFIABLE PRODUCT WAS RETURNED. A BLOOD-LIKE SUBSTANCE WAS SEEN ON THE SUTURE. IN ADDITION, THE SUTURE WAS COATED WITH AN UNK WHITE POWDER-LIKE MATERIAL, AND OTHER UNK MATERIALS (A TRANSLUCENT PAPER-LIKE MEMBRANE, MULTIPLE HAIR/FIBERS, AND MULTIPLE HARD AND IRREGULARLY SHAPED MASSES) WERE ATTACHED TO OR RETURNED LOOSE WITH THE SUTURE. NO VISUAL ANOMALIES WERE NOTED. A PHOTOGRAPHIC IMAGE WAS RECEIVED WITH THE COMPLAINT. THE COLOR IMAGE REVEALED A REDDENED AREA ON A PT'S LIMB. A SCAB-LIKE SORE IS SEEN WITHIN THE REDDENED AREA. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATE 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 INSTRUCTIONS FOR USE (IFU) CAUTION 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. THE ANGIO-SEAL DEVICE PT'S INFO GUIDE, WHICH THE PT IS INSTRUCTED TO CARRY WITH THEM FOR 90 DAYS INSTRUCTS THE PT TO REMOVE THE DRESSING AFTER 24 HRS AND CLEAN THE AREA WITH MILD SOAP AND WATER AND DRY THE AREA. THE SITE SHOULD BE COVERED WITH A BAND-AGE AND CHANGED DAILY OR IF IT BECOMES WET, UNTIL THE SKIN HEALS. THE PT IS ALSO INSTRUCTED TO CONTACT THE PHYSICIAN IMMEDIATELY IF THEY DEVELOP A FEVER, PERSISTENT TENDERNESS IN THE GROIN OR SWELLING, WOUND DRAINAGE, OR REDNESS AND/OR WARMTH AT THE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL WAS DEPLOYED IN THE RIGHT FEMORAL ARTERIOTOMY, POST ANGIOPLASTY. APPROX 4 DAYS LATER, THE PT DEVELOPED A RED PATCH ON THE LOWER RIGHT LEG BELOW THE KNEE, NEAR THE ANKLE. THE PT SAW THEIR GENERAL PHYSICIAN WHO PRESCRIBED ANTIBIOTICS (DOSE UNK). SEVERAL MONTHS LATER, THE RED PATCH WAS STILL THERE AND THE PT'S PHYSICIAN WROTE TO THE CARDIOLOGIST, WHO PERFORMED THE PROCEDURE, TO LET HIM KNOW ABOUT THE CONTINUED REDNESS. THE CARDIOLOGIST SAW THE PT IN THE CLINIC AND REPORTED THAT THE PT'S LEG STILL LOOKED RED AND THAT IT LOOKED LIKE AN EMBOLIC EVENT. THE PT TOLD THE CARDIOLOGIST THAT HE WAS PICKING AT THE SITE AND PICKED SOME SUTURE OUT OF THE WOUND. THE PT WAS REPORTED AS FINE AFTER THE INITIAL PROCEDURE AND THE CURRENT STATUS IS THE PT STILL HAS A RED PATCH ON THE LOWER LEFT LEG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other THE PT WAS TAKING PRESCRIBED ANTI-COAGULANTS