BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1923307 · Received December 13, 2010

    Report

    Report Number
    2953144-2010-03203
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE SHEATH WAS FULLY SLIT, INDICATING THAT THE THUMB ADVANCER WAS FULLY DEPLOYED TO BE ABLE TO COMPLETE THE SHEATH SPLITTING. THIS OBSERVATION CONTRADICTED THE REPORTED EXPERIENCE. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE CLIP WAS FIRED, BUT WAS CAUGHT AT THE DISTAL END OF THE DELIVERY TUBESET INSTEAD OF FULLY ADVANCED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. THE CLIP CAUGHT AT THE DISTAL END DIRECTLY RESULTED IN DIFFICULT DEVICE REMOVAL. THE ACCESS PORTS AND SAFETY RELEASE MECHANISM WERE SUCCESSFULLY UTILIZED TO UNLOCK THE THUMB ADVANCER AND SAFELY REMOVE THE DEVICE FROM THE PATIENTS ANATOMY. AS THE THUMB ADVANCER WAS MANUALLY RETRACTED AFTER BEING UNLOCKED, THE DELIVERY TUBESET WAS ALSO PULLED BACK. THIS CAUSED THE CLIP TO FALL OFF THE TUBESET AND LAND ON THE FLEX-GUIDE AS OBSERVED. HOWEVER, INSPECTION OF THE DEVICE REVEALED NO ABNORMAL OBSERVATIONS THAT COULD PREVENT THE CLIP FROM BEING FULLY DELIVERED TO THE ACCESS SITE. DURING LAB TESTING, THE DEVICE WAS CLEANED AND ASSEMBLED FOR DEPLOYMENT. THE RESULT WAS SUCCESSFUL AS DESIGNED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED AND THE ROOT CAUSE FOR THE MISLOCATED CLIP AT THE DISTAL END OF THE TUBESET COULD NOT BE DETERMINED BASED ON OUR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. (WEIGHT): THE PATIENT WAS REPORTED TO HAVE AN AVERAGE WEIGHT, NOT OBESE. (B)(4). DURING PROCESSING OF THIS COMPLAINT ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    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 COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE PHYSICIAN COULD NOT COMPLETE THE THUMB ADVANCEMENT STEP AND USED THE SAFETY RELEASE BUTTON TO REMOVE THE DEVICE. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT 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-REDWOOD CITY 920076H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention