BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1902095 · Received November 10, 2010

    Report

    Report Number
    2953144-2010-02804
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE DEVICE WAS FULLY CLIP DEPLOYED. THE THUMB ADVANCER WAS LOCKED IN THE #3 POSITION. THE VESSEL LOCATOR WINGS WERE COLLAPSED AND UNDAMAGED. THE TUBES WERE CORRECTLY ALIGNED IN THE POST DEPLOYED POSITIONS AT THE DISTAL END. THE BULBOUS SHAPE OF THE DISTAL TIP OF THE SHEATH AND THE PRESENCE OF THE CLIP INDICATES IT WAS STRETCHED BEYOND THE DISTAL END OF THE EXCHANGE SHEATH DURING THUMB ADVANCEMENT CAPTURING THE CLIP DURING DEPLOYMENT. A POSSIBLE CAUSE FOR THE EXCHANGE SHEATH STRETCHING IS A TIGHT TISSUE TRACT. INSTEAD OF THE TUBESET SLIDING EASILY WITHIN THE SHEATH, TISSUE COMPRESSION FORCES MAY CAUSE THE SHEATH TO DRAG ALONG WITH THE TUBESET AS IT IS DISTALLY ADVANCED. SUBSEQUENTLY, THE SHEATH ELONGATES WHICH CAN CAUSE INTERFERENCE WITH CLIP DEPLOYMENT. THIS TYPE OF DAMAGE IS GENERALLY CAUSE BY EXCESSIVE RESISTANCE; HOWEVER NO RESISTANCE WAS REPORTED IN THIS CASE. THE SAFETY RELEASE ROD WAS FOUND TO HAVE BEEN PUSHER INWARD OUT OF ITS RETAINING TABS, WHICH INDICATES AN ATTEMPT, WAS MADE TO COLLAPSE THE VESSEL LOCATOR WINGS USING THE SAFETY RELEASE BUTTON, AFTER THE CLIP WAS DEPLOYED BUT BEFORE THE THUMB ADVANCER WAS RETRACTED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR STRETCHED SHEATH AND CAPTURED CLIP IS RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING LIQUID WASTE LEAK ON THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEMS THAT WAS CAUSED BY THE CRACKED GREY COLORED HYDRO CANISTER LIDS. THERE IS NO INDICATION THAT ANY PERSONNEL WERE EXPOSED TO CHEMICAL OR BIO-HAZARDOUS MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN NOT TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE SHEATH DID NOT SPLIT COMPLETELY AND THE ATTEMPT TO USE THE SAFETY RELEASE BUTTON WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED USING ASSERTIVE PULL AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 920076H

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention