BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2040315 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02387
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS PARTIALLY DEPLOYED WITHOUT ITS RETURNED EXCHANGE SHEATH INSTALLED. THE PLUNGER WAS DEPLOYED WITH SUBSEQUENT VESSEL LOCATOR DEPLOYMENT. THE THUMB ADVANCER/DELIVERY TUBE SUBASSEMBLY WAS PARTIALLY DEPLOYED WITH ITS INITIAL DISTAL DEPLOYMENT DUE TO THE PLUNGERS DEPLOYMENT. THE DEPLOYED VESSEL LOCATOR WAS UNDAMAGED. INSPECTION OF THE CUTTER REVEALED THE CUTTER TO BE BENT BACKWARD WITH A DAMAGED CUTTING BLADE, FACING TOWARD THE PROXIMAL END OF THE DEVICE AWAY FROM ITS NORMAL DISTAL POINTING DIRECTION. THERE WAS NO DETECTED OBSTRUCTION WITHIN THE HANDLE TO RESTRICT THE EXCHANGE SHEATH INSTALLATION ONTO THE HANDLE OF THE DEVICE. THE EXCHANGE SHEATH HUB PRESENTED A DAMAGED PROXIMAL END CAP. THE TYPE OF DAMAGE SUSTAINED TO THE CUTTER AND EXCHANGE SHEATH HUB END CAP IS CONSISTENT WITH THE OPERATOR STRIKING THE CUTTER WITH THE HUB END CAP DURING EXCHANGE SHEATH INSTALLATION. IT COULD NOT BE DETERMINED IF THE CUTTER HAD BEEN BENT PRIOR TO THE PHYSICIAN ATTEMPTING TO INSTALL THE EXCHANGE SHEATH ONTO THE DEVICE WHICH WOULD HAVE CAUSED THE HUB END CAP TO STRIKE THE CUTTER BLADE, DAMAGING THE CUTTER AND CAUSING THE CUTTERS DIRECTIONAL POSITION TO BE ALTERED. THERE WERE NO OTHER OBSERVATIONS ON THE DEVICE TO REPORT. 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 WAS PERFORMED FOR THE LOT AND THERE HAVE BEEN NO OTHER REPORTED INCIDENTS OF AN INABILITY TO INSTALL THE EXCHANGE SHEATH ONTO THE STARCLOSE SE DEVICE WITH THIS LOT NUMBER. NO ROOT CAUSE COULD BE DETERMINED FOR THE DETECTED FAILURE MODE AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). (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 DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE COULD NOT BE CLICKED ONTO THE EXCHANGE SHEATH. A SECOND STARCLOSE SE DEVICE WAS USED SUCCESSFULLY 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 860306H

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention