BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1902299 · Received November 11, 2010

    Report

    Report Number
    2953144-2010-02836
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 22, 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
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE GARAGE LEAVES HAD PUNCTURED AND SHREDDED THE SHEATH DURING THE THUMB ADVANCER DEPLOYMENT, RESULTING IN BENT GARAGE LEAVES AND STRETCHED SHEATH AS OBSERVED. ALSO, THIS WOULD CREATE RESISTANCE TO THE THUMB ADVANCER DEPLOYMENT AS REPORTED. SUBSEQUENTLY, BECAUSE THE SHEATH WAS ELONGATED, THE CLIP TINES PUNCTURED INTO THE SHEATH, RESULTING IN THE CLIP BEING CAPTURED INSTEAD OF FULLY DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. THE CLIP WAS NOT RETURNED WITH THE DEVICE. BASED ON OUR INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR TORN AND STRETCHED SHEATH THAT CAPTURED THE CLIP IS TIGHT TISSUE TRACT. INSTEAD OF THE TUBESET SLIDING EASILY WITHIN THE SHEATH WHILE ADVANCING THE THUMB ADVANCER, TISSUE COMPRESSION FORCES MAY CAUSE THE SHEATH TO DRAG ALONG WITH THE TUBESET AS IT IS DISTALLY ADVANCED, RESULTING IN THE GARAGE LEAVES OF THE TUBESET PUNCTURED AND SHREDDED THE SHEATH. SUBSEQUENTLY, THE SHEATH ELONGATES WHICH CAN CAUSE INTERFERENCE WITH CLIP DEPLOYMENT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT ADDITIONAL INFORMATION RECEIVED STATED, ARTERIOTOMY CLOSURE WAS ATTEMPTED AT THE RIGHT COMMON FEMORAL ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE STARCLOSE SE DID NOT WORK AS EXPECTED. THE STARCLOSE SE DID NOT CLICK IN POSITION 3. WHEN INSPECTING, THE CLIP WAS FOUND STUCK IN THE DISTAL END OF THE TUBE. IT IS NOT KNOWN HOW HEMOSTASIS WAS ACHIEVED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT ADDITIONAL INFORMATION RECEIVED INDICATES VESSEL CLOSURE FOLLOWED A DIAGNOSTIC ANGIOGRAPHY. REPORTEDLY, RESISTANCE WAS FELT DURING THE THUMB ADVANCEMENT STEP, HOWEVER, THE STEP WAS COMPLETED (THE ARROWS ALIGNED AND A CLICK WAS HEARD). THE CLIP WAS DELIVERED, BUT HEMOSTASIS WAS NOT ACHIEVED. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION WITH NO COMPLICATIONS TO THE PATIENT.

    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 920096H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention