BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2042142 · Received April 6, 2011

    Report

    Report Number
    2024168-2011-02409
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY CLIP DEPLOYED. THE CLIP WAS NOT RETURNED. ALL EXTERNAL OBSERVATIONS OF THE HANDLE AND FULLY SLIT SHEATH WERE NORMAL FOR A CLIP DEPLOYED DEVICE. THE GARAGE TUBE LEAVES WERE BOWED AND THE VESSEL LOCATOR WAS RETRACTED INTO THE DISTAL END OF THE DELIVERY TUBE AND PRESENTED DAMAGED VESSEL LOCATOR WINGS (VLW). INSPECTION OF THE INTERNAL DEVICE COMPONENTS INDICATED ALL PARTS WERE UNDAMAGED AND IN THEIR PROPER POST CLIP DEPLOYED POSITIONS. THE FLEX GUIDE/VESSEL LOCATOR WAS DISTALLY DISPLACED AND IT WAS NOTED THAT THE PUSHER BODY JOINT WAS INTACT AND ALL 4 VLW WERE BENT, BUT INTACT WITH SECURE ATTACHMENT POINTS. THERE WERE NO OTHER OBSERVATIONS. IT WAS NOT POSSIBLE TO CONFIRM IF THE CLIP WAS CAPTURED ON THE END OF THE DEVICE AS REPORTED. THE DAMAGED VLW MAY HAVE BEEN MISTAKEN FOR THE CLIP, BUT THAT COULD NOT BE CONFIRMED. THE BOWED GARAGE TUBE LEAVES ARE CONSISTENT WITH A TIGHT TISSUE TRACT POSSIBLY DUE TO AN INSUFFICIENT NICK AND SPREAD; HOWEVER, THIS WAS NOT REPORTED. THERE WAS NO RESISTANCE REPORTED DURING DEVICE DEPLOYMENT AND NO ANATOMICAL INFORMATION WAS PROVIDED THAT MAY HAVE CONTRIBUTED TO THE OBSERVATION. A POSSIBLE CAUSE FOR THE CONDITION OF THE WINGS MAY HAVE BEEN THE COMPACTION OF TISSUE BETWEEN THE DEPLOYED LOCATOR WINGS AND THE DISTAL END OF THE DEVICE CLIP DELIVERY TUBE BENDING THE WINGS DISTALLY. THIS CONDITION CAN RESULT IN THE INABILITY OF THE LOCATOR WINGS TO RETRACT PROPERLY INTO THE CLIP DELIVERY TUBE AFTER CLIP DEPLOYMENT, REQUIRING COUNTER-TRACTION AND FORCEFUL REMOVAL OF THE DEVICE FROM THE PATIENT, WHICH MAY RESULT IN BENT LOCATOR WINGS. HOWEVER, THERE WAS NO REPORT OF ANY RESISTANCE DURING DEVICE REMOVAL POST CLIP DEPLOYMENT OR ANATOMICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE OBSERVATION. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE FOR THIS LOT WAS PERFORMED AND THERE HAVE BEEN NO OTHER REPORTED CASES FOR THE DEPLOYED CLIP BEING CAPTURED ON THE DISTAL END OF THE DEVICE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE CLIP WAS DEPLOYED, THE DEVICE WAS REMOVED FROM THE ANATOMY AND BLEEDING OCCURRED. PRESSURE WAS APPLIED AND A HEMATOMA DEVELOPED. THE CLIP WAS THEN FOUND AT THE END OF THE DEVICE. HEMOSTASIS WAS APPLIED WITH MANUAL COMPRESSION FOR 20 MINUTES. THERE WAS NO FURTHER TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 890296H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention