BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1923806 · Received December 14, 2010

    Report

    Report Number
    2953144-2010-03216
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    July 21, 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
    NY, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THE THUMB ADVANCER HAD BEEN RETRACTED PROXIMALLY, WHICH IS CONSISTENT WITH THE REPORTED EXPERIENCE. THERE WAS NO DAMAGED DETECTED WITH THE DEVICE THAT WOULD CONTRIBUTE TO THE REPORTED DIFFICULTY ENCOUNTERED DURING THUMB ADVANCEMENT; HOWEVER, TISSUE COMPACTION BETWEEN THE VESSEL LOCATORS AND/OR A TIGHT TISSUE TRACT CAN CREATE RESISTANCE DURING THUMB ADVANCER DEPLOYMENT. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, WHEN EXCESSIVE RESISTANCE IS EXPERIENCED DURING THUMB ADVANCER DEPLOYMENT MANUALLY COLLAPSE THE LOCATOR WINGS AND REMOVE THE DEVICE. THIS WAS NOT FOLLOWED IN THIS CASE AS EVIDENCED BY THE DAMAGE TO THE DEVICE. BASED ON THE EVALUATION FINDINGS AND THE REPORTED INFORMATION, THE PROBABLE ROOT CAUSE FOR THE REPORTED EVENT IS DUE TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    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 A DIAGNOSTIC PROCEDURE. REPORTEDLY, DIFFICULTY WAS ENCOUNTERED DURING THUMB ADVANCER DEPLOYMENT AND EXCHANGE SHEATH SPLITTING COULD NOT BE COMPLETED. THE SAFETY RELEASE WAS ACTIVATED, RETRACTING THE LOCATOR WINGS, WHICH RELEASED THE DEVICE FROM THE PATIENT ANATOMY. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGHT 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 900276H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention