BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2132881 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04325
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED INCIDENT. A MISLOCATED CLIP CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO MANUFACTURING, INADEQUATE NICK AND SPREAD, IMPROPER SEATING OF THE CLIP DELIVERY TUBE AT THE ACCESS SITE, NOT MAINTAINING DOWNWARD PRESSURE AND DEVICE STABILITY WHILE DEPRESSING THE DEPLOYMENT BUTTON WITH THE RIGHT THUMB, INCORRECT ANGLE OF THE DEVICE DURING CLIP DEPLOYMENT (CLICK 4), WHICH SHOULD BE 60-75 DEGREES, AND RETRACTION OF THE DEVICE DURING CLIP DEPLOYMENT (CLICK 4), CAN POTENTIALLY CAUSE THE EXPERIENCED EVENT. THIS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT, BUT CANNOT BE CONFIRMED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INFORMATION PROVIDED THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN IN TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A SCARRED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CONNECTING THE SHEATH TO THE DEVICE, DURING THUMB ADVANCEMENT, THERE WAS A LOT OF NOISE AND RESISTANCE. AN ATTEMPT WAS MADE TO DEPLOY THE CLIP (STEP# 4), BUT UNSUCCESSFUL. PER THE INSTRUCTIONS FOR USE, THE SAFETY RELEASE BUTTON AND THE ACCESS PORTS WERE USED AND THE DEVICE WAS REMOVED FROM THE ANATOMY. UPON REMOVAL, THE CLIP WAS OBSERVED TO BE LOCATED HALF WAY INSIDE THE SHEATH. MANUAL ARTERIAL COMPRESSION WAS APPLIED FOR 15 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 030026H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention