BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1823411 · Received August 25, 2010

    Report

    Report Number
    2182269-2010-00158
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PT ARTERIES >5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) PRECAUTION THE USE OF THE ANGIO-SEAL IN PEDIATRIC PTS OR OTHERS WITH SMALL FEMORAL ARTERY SIZE (<4 MM IN DIAMETER). SMALL FEMORAL ARTERY SIZE MAY PREVENT THE ANGIO-SEAL ANCHOR FROM DEPLOYING PROPERLY IN THESE PTS. THE ANGIO-SEAL DEVICE PT'S INFO GUIDE, WHICH THE PT IS INSTRUCTED TO CARRY WITH THEM FOR 90 DAYS STATES SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, IF ANY OF THE FOLLOWING SYMPTOMS ARE EXPERIENCED, THE PT IS TO CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THEIR PT INFO CARD: FEVER, BLEEDING, PERSISTENT TENDERNESS 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 A PT UNDERWENT A DIAGNOSTIC CARDIAC CATHETERIZATION ON (B)(6)2010. AN ANGIO-SEAL WAS PLACED POST PROCEDURE. A PRE-DEPLOYMENT FEMORAL ANGIOGRAM HAD BEEN PERFORMED SHOWING A 4 TO 5 MM VESSEL WITH VERY SLIGHT PERIPHERAL VASCULAR DISEASE (PVD). SOMETIME BETWEEN (B)(6)2010 AND (B)(6)2010, THE PT DEVELOPED A COLD LEG. ON (B)(6)2010, THE PT RETURNED TO THE CATH LAB FOR EVAL OF THE RIGHT COMMON FEMORAL ARTERY WITH FLUOROSCOPY. AN OCCLUSION WAS DISCOVERED AT THE LEVEL OF THE FEMORAL HEAD. A VASCULAR SURGEON SUCCESSFULLY OPENED THE VESSEL WITH ANGIOPLASTY AND ANGIOSCULPT. THE PT RECOVERED FINE AND HAS BEEN RELEASED FROM THE HOSPITAL. THE PT WAS PRESCRIBED MEDICATION (COUMADIN, DOSE UNK) AND WILL BE MONITORED WITH ULTRASOUND FOLLOW-UP APPOINTMENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R