BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2130201 · Received June 10, 2011

    Report

    Report Number
    2182269-2011-00103
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    March 22, 2011
    Report Date
    June 10, 2011
    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 REC'D, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATE THAT IF THE ANGIO-SEAL DEVICE DOES NOT ANCHOR IN THE ARTERY DUE TO IMPROPER ORIENTATION OF THE ANCHOR OR PT VASCULAR ANATOMY, ABSORBABLE COMPONENTS AND DELIVERY SYS SHOULD BE WITHDRAWN FROM THE PT. HEMOSTASIS CAN THEN BE ACHIEVED BY APPLYING MANUAL PRESSURE. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) INSTRUCTS THE USER NOT TO USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS PROXIMAL TO THE INGUINAL LIGAMENT AS THIS MAY RESULT IN A RETROPERITONEAL BLEED. 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 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. A TRAINING RECORD WAS NOT FOUND FOR THE DEPLOYING PHYSICIAN. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS THAT THE ANGIO-SEAL DEVICE IS TO BE USED ONLY BY A LICENSED PHYSICIAN (OR OTHER HEALTH CARE PROFESSIONAL AUTHORIZED BY OR UNDER THE DIRECTION OF SUCH PHYSICIAN) POSSESSING ADEQUATE INSTRUCTION IN THE USE OF THE DEVICE, E.G., PARTICIPATION IN AN ANGIO-SEAL PHYSICIAN INSTRUCTION PROGRAM OR EQUIVALENT. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) RECOMMENDS THAT A PRE-PLACEMENT ARTERIAL ANGIOGRAM BE PERFORMED TO ENSURE CORRECT PLACEMENT OF THE DEVICE IN THE COMMON FEMORAL ARTERY (CFA).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE FOLLOWING AN ELECTIVE DIAGNOSTIC ANGIOGRAPHIC PROCEDURE. ACCESS WAS GAINED VIA THE RIGHT COMMON FEMORAL ARTERY. THE PUNCTURE LOCATION WAS REPORTEDLY HIGH WHICH MAY HAVE CAUSED THE PHYSICIAN DIFFICULTIES WHEN ADVANCING THE INSERTION SHEATH. THE VESSEL WAS REPORTEDLY QUITE FIBROUS CAUSING MILD RESISTANCE. HOWEVER, THE ANGIO-SEAL DEPLOYED AND FELT NORMAL. HEPARIN (DOSAGE UNK) WAS GIVEN DURING THE PROCEDURE. AFTER THE PT RETURNED TO THE CORONARY CARE UNIT (CCU), A DROP IN BLOOD PRESSURE OCCURRED. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A RETROPERITONEAL BLEED. THE PT UNDERWENT A LAPAROTOMY. THE ANGIO-SEAL WAS NOT REMOVED, BUT THE VASCULAR SURGEONS REPORTED THAT THE ANGIO-SEAL WAS NOT FULLY DEPLOYED AND THAT THE ANGIO-SEAL WAS DEPLOYED IN FIBROUS TISSUE. THE PT'S HOSP STAY WAS EXTENDED DUE TO AN INFECTED WOUND. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R