BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1980120 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00718
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 13, 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). EVALUATION OF THE RETURNED DEVICE FOUND IT PARTIALLY DEPLOYED. THE EXCHANGE SHEATH HAD NOT BEEN ATTACHED TO THE CLIP APPLIER AND WAS NOT RETURNED WITH THE DEVICE. BLOOD WAS PRESENT IN THE DEVICE INDICATING INTRODUCTION INTO THE PATIENT ANATOMY. THE PLUNGER WAS ACTIVATED AND THE VESSEL LOCATOR WINGS WERE IN THE OPEN POSITION. THE THUMB ADVANCER HAD BEEN FULLY DEPLOYED BUT THE CLIP HAD NOT BEEN DEPLOYED. THE VESSEL LOCATOR WING WERE PARTIALLY COLLAPSED DUE TO THE DRIED BLOOD BETWEEN THE SUPPORT TUBE AND FLEX GUIDE. DURING TESTING THE SAFETY RELEASE WAS ACTIVATED RELEASING THE PLUNGER. THE DEVICE WAS CLEANED, DURING CLEANING EXCESSIVE AMOUNTS OF BLOOD AND TISSUE WAS FOUND PACKED IN THE DISTAL END OF THE TUBESET AND IT IS CONSIDERED A CONTRIBUTING FACTOR IN THE REPORTED EXPERIENCE OF CLICK NOT HEARD AFTER COMPLETING THUMB ADVANCEMENT, AND IT IS NOT CONSISTENT WITH THE DEVICE INSTRUCTIONS FOR USE. AFTER THE DEVICE WAS CLEANED THE CLIP WAS DEPLOYED WITHOUT DIFFICULTY. THE EXCHANGE SHEATH HUB CAN NOT BE ATTACHED TO THE CLIP APPLIER AFTER THE TUBESET/THUMB ADVANCER HAS BEEN ADVANCED. DOING SO WOULD DAMAGE THE CUTTER AND AFFECT THE SHEATH SLITTING. BASED ON THE INVESTIGATION AND TEST RESULTS, THE PROBABLE ROOT CAUSE FOR THE REPORTED EXPERIENCE IS DUE TO INCORRECT TECHNIQUE/PROCEDURE DURING USE. THERE WAS NO MANUFACTURING OR QUALITY ISSUE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - INCORRECT REMOVAL. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, STEP #3 (THUMB ADVANCEMENT) WAS COMPLETED BUT A CLICK WAS NOT HEARD; THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY AND ANOTHER STARCLOSE SE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THE MANUFACTURER REPRESENTATIVE COLLECTED THE DEVICE AND INDICATED THE LOCATOR WINGS WERE IN THE OPEN POSITION. 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 930066H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention HEPARIN