BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1990650 · Received February 15, 2011

    Report

    Report Number
    2024168-2011-00917
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PATIENT WEIGHT WAS DESCRIBED AS APPROXIMATELY (B)(6). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY DEPLOYED. THE EXTERNAL AND INTERNAL COMPONENTS WERE FOUND IN THE CORRECT POST DEPLOYED POSITIONS AND UNDAMAGED WITH THE EXCEPTION OF THE LOCATOR WINGS. THE LOCATOR WINGS WERE SLIGHTLY BENT INDICATING THE ENCOUNTERED RESISTANCE DURING DEPLOYMENT. BASED ON THIS FINDING, THE REPORTED EXPERIENCE IS CONFIRMED. AT CLIP DEPLOYMENT THE VESSEL LOCATORS ARE DESIGNED TO AUTOMATICALLY COLLAPSE AND NOT INTERFERE WITH CLIP DELIVERY. THE MOST PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS COMPACTION OF SUBCUTANEOUS TISSUE BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS DURING THUMB ADVANCER DEPLOYMENT. THIS MAY CREATE DISTAL FORCES RESULTING IN BENDING OF THE LOCATOR WINGS CAUSING THEM TO INTERFERE WITH CLIP DEPLOYMENT. BASED ON THE INVESTIGATION THE PROBABLE ROOT CAUSE FOR THE REPORTED EXPERIENCE IS RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN, TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER A CARDIAC CATHETERIZATION PROCEDURE. REPORTEDLY, THE CLIP WAS DEPLOYED, AND WHEN THE DEVICE BODY WAS REMOVED FROM THE PATIENT IT WAS OBSERVED THAT THE CLIP WAS LOCATED AT THE END OF THE DEVICE, AND THE LOCATOR WINGS WERE IN THE CLOSED POSITION. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. 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 940456H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention