BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2173981 · Received July 24, 2011

    Report

    Report Number
    2024168-2011-05104
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. WITHOUT THE PRODUCT TO EXAMINE A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT THE RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, SAMPLINGS OF FINISHED DEVICES ARE TESTED TO VERIFY FUNCTIONALITY OF THE DEVICE. A STARCLOSE SE DEVICE CAN BE DIFFICULT TO REMOVE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, TISSUE COMPACTION THAT RESULTS IN DISTAL FORCE BEING APPLIED TO THE LOCATOR WINGS BENDING THEM DISTALLY AND RESTRICTING THEIR PROPER RETRACTION INTO THE CLIP DELIVERY TUBESET. THIS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE PRODUCT EXPERIENCE, BUT COULD NOT BE CONFIRMED. BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED, A REVIEW OF THE LOT HISTORY RECORD FOR THIS PRODUCT AND A QUERY OF THE COMPLAINT-HANDLING DATABASE COULD NOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE AND THE INSPECTION CRITERIA THERE DO NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO A 100% INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY THROUGH A 6F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ACHIEVED WITH THE STARCLOSE SE DEVICE. REPORTEDLY, AFTER CLIP DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, A DILATOR WAS INSERTED INTO THE ACCESS PORTS UNLOCKING THE THUMB ADVANCER AND CLIP DELIVERY TUBESET ENABLING THEM TO BE RETRACTED PROXIMALLY, WHICH RELEASED THE DEVICE FROM THE TISSUE TRACT. WHEN THE DEVICE WAS REMOVED, THE CLIP WAS DEPLOYED IN THE INTENDED LOCATION IN THE VESSEL WITH NO BLEEDING, WHICH INDICATED HEMOSTASIS WAS ACHIEVED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. REPORTEDLY, THE OPERATOR IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PROCEDURAL SHEATH 6F