BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2231206 · Received August 25, 2011

    Report

    Report Number
    2182269-2011-00134
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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 INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) INSTRUCTS THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTICS PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRAST MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ANGIO-SEAL WAS PLACED AFTER A CATHETERIZATION PROCEDURE. MONTHS AFTER THE CATHETERIZATION PROCEDURE THE PT RETURNED TO THE HOSP WITH LEG PAIN AND HAD A WEAK PEDAL PULSE IN HER FOOT. AN ANGIOGRAM AND ULTRASOUND WERE PERFORMED, WHICH REVEALED VASCULAR INSUFFICIENCY. A STENT WAS PLACED IN THE COMMON FEMORAL ARTERY TO REVASCULARIZE THE OCCLUDED VESSEL. THE PT'S HOSPITALIZATION WAS ALSO EXTENDED DUE TO THIS EVENT. THE PT RECOVERED AND WAS LATER DISCHARGED FROM THE HOSP. THE EVENT DATE WAS MONTH SPECIFIC, OCCURRING SOMETIME DURING (B)(6) 2011.

    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