BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 4252029 · Received November 14, 2014

    Report

    Report Number
    3003681312-2014-00111
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    PP930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATE THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE ARE 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

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF CEREBROVASCULAR AND ENDOVASCULAR NEUROSURGERY: SEP 2014; 16(3): 275-280. (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A DIAGNOSTIC CEREBRAL ANGIOGRAM, FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN SHOWING THE PRESENCE OF A LEFT PARIETAL LESION CONCERNING FOR A VASCULAR MALFORMATION. THE RIGHT COMMON FEMORAL ARTERY WAS SELECTIVELY CATHETERIZED USING A 5F SHEATH AND A 5F HOCKEY-STICK DIAGNOSTIC ANGIOCATHETER, AND A 0.035 GLIDEWIRE WAS USED FOR CATHETERIZATION OF THE LEFT INTERNAL CAROTID ARTERY. A 6F ANGIO-SEAL CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED AT THE END OF THE PROCEDURE TO OBTAIN ARTERY CLOSURE. POSTOPERATIVELY, THE PATIENT HAD A SMALL PUNCTURE SITE HEMATOMA WITH GOOD DISTAL PEDAL PULSES, WHICH APPEARED STABLE AND THE PATIENT WAS DISCHARGED HOME. THREE DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED A PERSISTENT RIGHT GROIN PAIN WITH CLINICAL SIGNS OF VASCULAR CLAUDICATION IN THE RIGHT LEG MANIFESTED BY CALF PAIN EXACERBATED BY AMBULATION. DUPLEX ULTRASOUND AND COMPUTED TOMOGRAPHY REVEALED A PARTIALLY OCCLUSIVE THROMBUS IN THE RIGHT COMMON FEMORAL ARTERY. A THROMBECTOMY REVEALED THE ANGIO-SEAL DEVICE INSIDE THE VESSEL INSTEAD OF A SUSPECTED THROMBUS. THE PATIENT WAS DISCHARGED IN A STABLE CONDITION ONE DAY AFTER THE SURGERY. DOI: 10.7461/JCEN.2014.16.3.275.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738226 ANGIO-SEAL DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL PUERTO RICO, B.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R