BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2800207 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06643
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(4) - FEMORAL ANGIOGRAM NOT PERFORMED, OPERATOR OF THE STARCLOSE SE WAS NOT TRAINED, AND ADEQUATE NICK AND SPREAD INCISION WAS NOT PERFORMED. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. REPORTEDLY, A FEMORAL ANGIOGRAM WAS NOT PERFORMED, THE OPERATOR OF THE STARCLOSE SE WAS NOT TRAINED, AND ADEQUATE NICK AND SPREAD INCISION WAS NOT PERFORMED. THE INSTRUCTIONS FOR USE STATES: PERFORM A FEMORAL ANGIOGRAM THROUGH THE SIDE PORT OF THE PROCEDURAL SHEATH TO DETERMINE THE LOCATION OF THE ARTERIOTOMY SITE, THE VESSEL SIZE, AND THE PRESENCE OF DISEASE (CALCIFIED PLAQUE, STENOSIS, CHRONIC OR ACUTE OCCLUSION), TORTUOSITY OR PRESENCE OF ARTERIAL WALL DISSECTION. REGARDING THE OPERATOR NOT BEING TRAINED THE IFU STATES: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN (OR ALLIED HEALTHCARE PROFESSIONALS, AUTHORIZED BY, OR UNDER THE DIRECTION OF, SUCH PHYSICIANS) WHO IS TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAS BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. REGARDING THE NICK AND SPREAD INCISION NOT BEING PERFORMED, THE IFU STATES: IT IS NECESSARY TO CREATE A 5-7 MM SKIN INCISION AT THE SHEATH SITE TO ACCOMMODATE THE INSERTION OF THE CLIP DELIVERY TUBE INTO THE TISSUE TRACT. THIS SHOULD BE DONE AT THE BEGINNING OF THE PROCEDURE PRIOR TO THE ADMINISTRATION OF ANTICOAGULANTS AND ANTIPLATELET AGENTS, IF POSSIBLE. CONSIDER BLUNT DISSECTION BY SINGLE SPREAD WITH SURGICAL INSTRUMENT IN THE SKIN INCISION, ESPECIALLY IN THOSE PATIENTS WITH SCAR TISSUE FROM PREVIOUS CATHETERIZATION PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT DOWNWARD PRESSURE WAS APPLIED FOR APPROXIMATELY 5 SECONDS, THE SYSTEM WAS THEN RETRACTED; HOWEVER, NO SUFFICIENT HEMOSTASIS COULD BE ACHIEVED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. NO ADEQUATE NICK AND SPREAD BEFORE INTRODUCING THE STARCLOSE SHEATH WAS PERFORMED AND LEAD TO PUCKERING OF THE SKIN AT THE ACCESS SITE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN HAS NOT BEEN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. 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-TEMECULA-CT 20518K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FHEPARIN