BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2872286 · Received December 13, 2012

    Report

    Report Number
    2024168-2012-07899
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 27, 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. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4): A FEMORAL ANGIOGRAM WAS NOT TAKEN. PER THE INSTRUCTIONS FOR USE: PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. ESTIMATED DATE OF OCCURRENCE, EVENT OCCURRED IN THE MONTH OF (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS REPORTED THAT A FEMORAL ANGIOGRAM WAS NOT TAKEN. THE STARCLOSE SE INSTRUCTION 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, EXCESSIVE RESISTANCE WAS FELT WHILE ADVANCING THE THUMB ADVANCER. THERE WAS CARVING OF THE SHEATH. THE SAFETY RELEASE MECHANISM WAS USED TO REMOVE THE DEVICE. HEMOSTASIS WAS ACHIEVED BY APPLYING MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. 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 20626K1

    Patients

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