BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2103468 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03714
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS RETURNED PARTIALLY DEPLOYED. INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE CLIP-FIRING MECHANISM WAS NOT ACTIVATED TO FIRE THE CLIP OFF THE DEVICE. THERE WERE NO ABNORMAL OBSERVATIONS THAT COULD PREVENT THE DEPLOYMENT BUTTON FROM BEING DEPRESSED TO FIRE THE CLIP. BECAUSE THE CLIP WAS NOT FIRED, THE LOCATOR WINGS WOULD NOT COLLAPSE AND THE PLUNGER WOULD NOT DISENGAGE AS OBSERVED. DURING TESTING, THE DEVICE WAS CLEANED, ASSEMBLED, AND DEPLOYED SUCCESSFULLY AS INTENDED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE REPORTED PRODUCT EXPERIENCE IS INCORRECT TECHNIQUE AS THE DEPLOYMENT BUTTON WAS NOT DEPRESSED AFTER COMPLETING THE THUMB ADVANCER STROKE TO FIRE THE CLIP OFF THE DEVICE. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS WITH REPORTED FAILURE TO DEPLOY THE CLIP. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    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, THE CLIP FAILED TO DEPLOY. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 010376H

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention