BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3250885 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04721
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 10, 2013
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED LOSS OF ARTERIAL ACCESS WHEN PULLING BACK THE DEVICE WAS CONFIRMED. BASED ON VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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.

    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. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, RETURNED DEVICE ANALYSIS FOUND THE THUMB ADVANCER STROKE AND SHEATH SPLITTING WERE INCOMPLETE AND THE CLIP WAS NOT FIRED AT ALL. THE RETURNED CONDITION INDICATED THAT THE DEVICE WAS INADVERTENTLY PULLED OUT OF THE ARTERY WHILE ADVANCING THE THUMB ADVANCER. THE REPORTER WAS CONTACTED FOR CLARIFICATION OF THE REPORTED EVENT AND ADDITIONAL INFORMATION WAS RECEIVED: WHAT THE PHYSICIAN SAW DID NOT LOOK LIKE A CLIP BUT APPEARED TO LOOK LIKE FLEXIBLE FINGERS (THE LEAVES OF THE GARAGE TUBE). THE PHYSICIAN ALSO INDICATED AS THE DEVICE WAS PULLED BACK TO VIEW THE CLIP DELIVERY TUBESET THE DEVICE PULLED OUT FROM THE VESSEL. REPORTEDLY. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC CEREBRAL ANGIOGRAM, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE. REPORTEDLY, THE CLIP WAS OBSERVED TO BE DEPLOYED ON THE DISTAL END OF THE DEVICE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353501 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 070366H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SHEATH: 5-FRENCH