BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2224497 · Received August 26, 2011

    Report

    Report Number
    2024168-2011-05966
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE COMPLAINT. LOSS OF ARTERIAL ACCESS CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, A MANUFACTURING DEFICIENCY, USER TECHNIQUE, AND PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, ALL DEVICES ARE VISUALLY INSPECTED. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. DEPLOYING THE DEVICE IN CHALLENGING ANATOMIES MAY CAUSE LOSS OF ARTERIAL ACCESS. A FEMORAL ANGIOGRAM DID NOT REVEAL CALCIFICATION AND NO OTHER RELEVANT PATIENT MEDICAL HISTORY WAS PROVIDED. USER TECHNIQUE SUCH AS INCOMPLETE STROKE OF PLUNGER, APPLYING EXCESSIVE TENSION AGAINST THE LOCATOR WINGS, OR INADEQUATE NICK AND SPREAD MAY RESULT IN LOSS OF ARTERIAL ACCESS. REPORTEDLY, THE USER WAS NOT TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. FURTHERMORE, THE DEVICE WAS USED IN AN 8F ACCESS SITE. THE STARCLOSE SE INSTRUCTIONS FOR USE (IFU) INDICATES THAT THE DEVICE 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. THE IFU FURTHER STATES THAT THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. A CONCLUSIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT DEVIATION FROM THE IFU, THE USE OF THE DEVICE BY AN UNTRAINED PHYSICIAN AND ITS USE IN A LARGER ACCESS SITE THAN THE DEVICE IS INDICATED FOR, CONTRIBUTED TO THE REPORTED LOSS OF ARTERIAL ACCESS. A REVIEW OF THE LOT HISTORY RECORD AND THE QUERY OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE DEVICE LOT NUMBER WAS NOT REPORTED. BASED ON THE REVIEW OF THE EVENT INFORMATION AND TESTING/INSPECTION CRITERIA FOR THIS DEVICE, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. PHYSICIAN IS NOT TRAINED AND USE OF A SHEATH THAT IS AGAINST THE RECOMMENDED SHEATH SIZE PER THE INSTRUCTIONS FOR USE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE COMPLETED; HOWEVER, INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER AN INTERVENTIONAL PROCEDURE WHICH USED AN 8F SHEATH. REPORTEDLY, AFTER DEPLOYING THE VESSEL LOCATOR WINGS AND GENTLY PULLING AGAINST THE ARTERIAL WALL TO CHECK FOR RESISTANCE, THE DEVICE LOST VESSEL ACCESS COMPLETELY. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS NOT TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8F