BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2025517 · Received March 21, 2011

    Report

    Report Number
    2024168-2011-01891
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY CLIP-DEPLOYED AND THE RETURNED CONDITION SUBSTANTIATED THE REPORTED EXPERIENCE. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE DISTAL END OF THE SHEATH WAS TORN AND STRETCHED DURING THUMB ADVANCER DEPLOYMENT. SUBSEQUENTLY, AS THE TRIGGER BUTTON WAS DEPRESSED TO FIRE THE CLIP, THE CLIP TINES PUNCTURED INTO THE SHEATH, RESULTING IN THE CLIP BEING CAPTURED WITHIN THE SHEATH INSTEAD OF DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS DESIGNED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE 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 TORN AND STRETCHED SHEATH. SUBSEQUENTLY, THE SHEATH ELONGATES WHICH CAN CAUSE INTERFERENCE WITH CLIP DEPLOYMENT. THE OBSERVED DAMAGE INDICATED THAT THERE WAS RESISTANCE ENCOUNTERED DURING THE THUMB ADVANCER DEPLOYMENT; HOWEVER, THIS WAS NOT REPORTED. THE INSTRUCTIONS FOR USE (IFU), UNDER THE PRECAUTIONS SECTION, STATES: THE STARCLOSE SE VASCULAR CLOSURE SYSTEM SHOULD BE USED ONLY BY OPERATORS TRAINED IN DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WHO HAVE BEEN CERTIFIED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR INC. ALSO, THE IFU, UNDER THE WARNINGS SECTION, STATES: DO NOT USE THE STARCLOSE SE VASCULAR CLOSURE SYSTEM IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA. PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. A REVIEW OF THE PRODUCT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. OPERATOR NOT TRAINED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    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 THE RIGHT COMMON FEMORAL ARTERY (RCFA) AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE STICK DONE AT THE RCFA WAS HIGH. THE STARCLOSE SE DEVICE WAS INSERTED, ALL DEPLOYMENT STEPS PERFORMED UNEVENTFULLY, AND WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S GROIN HEMOSTASIS WAS NOT ACHIEVED. DURING INSPECTION, THE CLIP WAS OBSERVED TO BE HANGING UP IN THE STARCLOSE SE DELIVERY SHEATH WITH THE WINGS RETRACTED. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT ADDITIONAL INFORMATION RECEIVED: THE ARTERIAL PUNCTURE WAS DONE ABOVE THE INFERIOR EPIGASTRIC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 900326H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention