BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2023908 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01817
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 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
    MI, 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 RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY DEPLOYED WITH THE THUMB ADVANCER UNLOCKED AND RETRACTED PROXIMALLY. THE VESSEL LOCATOR WINGS WERE BROKEN, WHICH IS CONSISTENT WITH DIFFICULT TO REMOVE DEVICE COMPLAINTS FINDINGS AND THIS CONFIRMED THE REPORTED EXPERIENCE AND THE INCIDENT DESCRIPTION. ALL THE BROKEN PARTS WERE RETURNED AND REMAINED SECURELY ATTACHED WITHIN THE LOCATOR. AT CLIP DEPLOYMENT THE VESSEL LOCATORS ARE DESIGNED TO AUTOMATICALLY COLLAPSE AND NOT INTERFERE WITH CLIP DELIVERY. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE BROKEN VESSEL LOCATOR WINGS IS COMPACTION OF SUBCUTANEOUS TISSUE BETWEEN THE DISTAL END OF THE TUBE SET AND THE LOCATOR WINGS DURING THUMB ADVANCER DEPLOYMENT. THIS MAY CREATE DISTAL FORCES RESULTING IN BENDING AND BREAKAGE OF THE LOCATOR WINGS AND SUBSEQUENT DIFFICULTY WITH DEVICE REMOVAL. NO MANUFACTURING DEFICIENCY WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS EVENT.

    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 THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC HEART CATHERIZATION PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE. IN ACCORDANCE WITH THE INSTRUCTION FOR USE AN ATTEMPT TO REMOVE THE STARCLOSE SE DEVICE BY RELEASING THE LOCKING MECHANISM ON THE THUMB ADVANCER USING THE ACCESS PORTS WAS MADE; HOWEVER, IT WAS UNSUCCESSFUL. THE DEVICE WAS ULTIMATELY REMOVED USING COUNTER-TRACTION AND ASSERTIVE PULL. ALTHOUGH THE LOCATOR WINGS WERE NOTED TO BE BROKEN, ALL OF THE PARTS OF THE LOCATOR WINGS REMAINED ATTACHED TO THE DISTAL-END OF THE DEVICE. MINIMAL BLEEDING CONTINUED FROM THE TISSUE TRACT REQUIRING THREE MINUTES OF MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 860306H

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention