BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1032119 · Received April 18, 2008

    Report

    Report Number
    2953144-2008-00745
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE WAS RECEIVED IN A CLIP DEPLOYED STATE. THE VESSEL LOCATOR WINGS WERE BENT AND NOT COLLAPSED INTO THE DISTAL END OF THE TUBE SET, CONSISTENT WITH USE IN A HEAVILY CALCIFIED AREA RESULTING IN CALCIFICATION INTERFERING WITH THE COLLAPSE OF THE VESSEL LOCATOR WINGS. THIS WOULD RESULT IN DIFFICULT REMOVAL CONDITION. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER NOT TO DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. THE SAFETY RELEASE NUT WAS PUSHED INWARDLY FORCEFULLY PUSHING THE SAFETY ROD OUT OF ITS TRACK AND CAUSING THE SAFETY BUSHING TO BECOME DISBANDED AND MOVED FROM THE BONDED POSITION. THIS FINDING IS CONSISTENT WITH THE REPORTED ATTEMPTED TO COLLAPSE THE VESSEL LOCATOR WINGS AFTER CLIP DEPLOYMENT. THE SAFETY RELEASE BUTTON IS NO LONGER OPERABLE AFTER CLIP DEPLOYMENT; IT CAN ONLY RELEASE THE LOCATORS ANYTIME BEFORE THE CLIP IS DEPLOYED. THE DISTAL TIP OF THE EXCHANGE SHEATH WAS FLARED INDICATING THE SHEATH WAS STRETCHED DURING DEPLOYMENT. THE OBSERVATIONS OF THE DEVICE DURING THIS INVESTIGATION ARE CONSISTENT WITH THE REPORTED EXPERIENCE. BASED ON THE FINDINGS OF THIS INVESTIGATION, THE ROOT CAUSE FOR THE EVENT IS DUE TO USER ERROR. NO MFG ISSUES WERE 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

    DEVICE MALFUNCTION: DIFFICULT TO REMOVE. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE: HEMATOMA, PAIN, FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED SCARRED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP THE DEVICE WAS DIFFICULT TO REMOVE. THE SAFETY RELEASE BUTTON AND THE VESSEL LOCATOR BUTTON WERE DEPRESSED AND AN ATTEMPT WAS MADE TO FORCEFULLY PULL THE DEVICE FROM THE VESSEL, BUT THE PT COMPLAINED OF PAIN. THE PHYSICIAN PERFORMED A NICK AND SPREAD AT THE VESSEL TRACT AND WAS ABLE TO REMOVE THE DEVICE. THE CLIP HAD DEPLOYED IN SCAR TISSUE AND IT WAS REMOVED WITH FORCEPS. A HEMATOMA OF LESS THAN 6CM WAS NOTED. THE HEMATOMA RESOLVED WHEN MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN FELT THE DEVICE WAS DIFFICULT TO REMOVE DUE TO SCAR TISSUE FROM THREE PREVIOUS CLOSURE PROCEDURES. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 62080-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention