BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 4792314 · Received May 22, 2015

    Report

    Report Number
    3003681312-2015-00041
    Event Type
    Injury
    Date Received
    May 22, 2015
    Report Date
    April 29, 2015
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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 ARTICLE, ¿LATE ONSET IATROGENIC LIMB ISCHAEMIA AFTER DEPLOYMENT OF AN ANGIO-SEAL VASCULAR CLOSURE DEVICE,¿ WHICH WAS PUBLISHED ONLINE TO THE BMJ CASE REPORTS 2015 ON 26 APRIL 2015: TWO PATIENTS UNDERWENT AND HAD SUBSEQUENT VASCULAR ACCESS SITE CLOSURE WITH ANGIO-SEAL VASCULAR CLOSURE DEVICES. THE DEVICES WERE DEPLOYED SUCCESSFULLY AT THE RIGHT COMMON FEMORAL ARTERY (CFA) ACCESS SITE WITH SUCCESSFUL HEMOSTASIS. THREE WEEKS LATER, BOTH PATIENTS PRESENTED WITH FEATURES OF LIMB ISCHAEMIA NEEDING FURTHER DIAGNOSTIC WORK-UP INCLUDING REPEAT ANGIOGRAPHY, WHICH REVEALED SUBTOTAL OCCLUSION OF RIGHT COMMON FEMORAL ARTERY AT THE LEVEL OF PRIOR ACCESS AND ANGIO-SEAL DEPLOYMENT SITE. BOTH THE PATIENTS UNDERWENT SUCCESSFUL SURGICAL REPAIR WITH RESTORATION OF DISTAL FLOW AND RESOLUTION OF SYMPTOMS. DOI: 10.1136/BCR-2015-209393. PLEASE REFERENCE MFR REPORT NUMBER 3003681312-2015-00043.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336618 ANGIO-SEAL DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL PUERTO RICO, B.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R