BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2191378 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05484
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED AND THE LOT NUMBER WAS NOT PROVIDED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT 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 PATIENT ANATOMY. MANUAL ARTERIAL COMPRESSION WAS APPLIED FOR FIVE MINUTES TO ACHIEVE HEMOSTASIS. DIFFICULTY IN REMOVING THE DEVICE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO A MANUFACTURING ISSUE, USER TECHNIQUE AND, PATIENT ANATOMICAL CONDITIONS, EACH WERE CONSIDERED. FEMORAL ANGIOGRAM REVEALED NO PRESENCE OF VESSEL CALCIFICATION, VESSEL TORTUOSITY, OR ACCESS SITE/GROIN SCARRING. HOWEVER, TISSUE COMPACTION THAT RESULTS IN A DISTAL FORCE BEING APPLIED TO THE LOCATOR WINGS, BENDING THEM DISTALLY, AND RESTRICTING THEIR PROPER RETRACTION INTO THE DELIVERY TUBESET MAY CAUSE THE REPORTED DIFFICULTY IN REMOVING THE DEVICE. NO INFORMATION REGARDING USER TECHNIQUE WAS PROVIDED; HOWEVER, IF DISTAL FORCE IS APPLIED TO THE LOCATOR WINGS, BENDING THEM DISTALLY, AND RESTRICTING THEIR PROPER RETRACTION INTO THE DELIVERY TUBESET MAY CAUSE THE REPORTED DIFFICULTY IN REMOVING THE DEVICE. A THOROUGH ANALYSIS COULD NOT BE PERFORMED ON THE PRODUCT BECAUSE IT WAS NOT RETURNED TO ABBOTT VASCULAR FOR INVESTIGATION; THEREFORE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY IN REMOVING THE DEVICE CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD WAS NOT PERFORMED BECAUSE THE DEVICE LOT NUMBER WAS NOT REPORTED. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE DEVICE LOT NUMBER WAS NOT REPORTED. BASED ON THE REVIEW OF EVENT INFORMATION AND TESTING/INSPECTION CRITERIA FOR THIS DEVICE, A PRODUCT QUALITY ISSUE WAS NOT NOTED. ALL DEVICES ARE VISUALLY INSPECTED. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED, TO INCLUDE THE RELEASE FROM THE TISSUE MODEL, TO VERIFY THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL PROCEDURE THROUGH A 6F SIZED SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A 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 PATIENT ANATOMY. MANUAL ARTERIAL COMPRESSION WAS APPLIED FOR FIVE MINUTES TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN WAS REPORTED TO BE 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 Required Intervention PROCEDURAL SHEATH 6F