BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1895444 · Received November 4, 2010

    Report

    Report Number
    2182269-2010-00208
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 7, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 8F ANGIO-SEAL VIP WAS SELECTED DEPLOYED IN THE RIGHT COMMON FEMORAL ARTERIOTOMY AFTER THE PT HAD PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). WHILE THE PT WAS STILL IN THE CATH LAB, BLEEDING OCCURRED FROM THE GROIN AND MANUAL COMPRESSION WAS APPLIED FOR APPROX 15 MINS. THE PT WAS SENT TO A DIFFERENT CLINIC. THAT EVENING, THE PT DEVELOPED PAIN AND ISCHEMIA IN THE RIGHT LEG. THE PT WAS SENT BACK TO A HOSPITAL; HOWEVER, IT WAS A DIFFERENT HOSPITAL THAN THE ONE WHERE THE PTCA WAS PERFORMED. THE NEXT DAY THE PT WENT TO VASCULAR SURGERY WHERE THE SURGEON PERFORMED A THROMBOENDARTERECTOMY IN THE RIGHT FEMORAL ARTERY. THE ANGIO-SEAL WAS REMOVED. THE PT WAS DISCHARGED (B)(6) 2010. ON (B)(6) 2010 THE SUTURES WERE REMOVED AND THE PT WAS REPORTED TO BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL NA 2924761

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R PLAVIX FOR ONE MONTH AFTER THE PTCA AND SURGERY.| THE PATIENT WAS GIVEN 100MG OF ASPIRIN AND 75MG OF