BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2896533 · Received December 28, 2012

    Report

    Report Number
    2182269-2012-00150
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS NOT RETURNED, OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE 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) 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.

    Description of Event or Problem · 1

    AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE FOLLOWING A CORONARY INTERVENTION WITH PLACEMENT OF A DRUG-ELUTING STENT. A PRE-DEPLOYMENT ANGIOGRAM WAS NOT PERFORMED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED FOLLOWING DEPLOYMENT. FIFTEEN MINUTES POST-PROCEDURE DURING TRANSFER OUTSIDE OF THE PROCEDURE ROOM, THE PATIENT COMPLAINED OF PAIN AND DEVELOPED A RETROPERITONEAL BLEED REQUIRING SURGICAL REPAIR. THE ANCHOR WAS NOT FOUND DURING THE SURGERY AND COULD NOT BE LOCATED WITH ULTRASOUND. THE PATIENT RECOVERED AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA 3744854

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R