BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3103083 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02904
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE CLIP FULLY DEPLOYED WITH THE THUMB ADVANCER UNLOCKED AND RETRACTED PROXIMAL. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, PROBABLE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE, WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE COULD NOT BE REMOVED. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE SAFETY RELEASE MECHANISM ACCESS PORTS AND COUNTER-TRACTION, ASSERTIVE PULL WERE USED TO FACILITATE DEVICE REMOVAL. THE CLIP ACHIEVED HEMOSTASIS; HOWEVER, MANUAL CONJUNCTIVE PRESSURE WAS APPLIED FOR 3 MINUTES PER STANDARD TREATMENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203654 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30103K1

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 6 FR