BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2991580 · Received March 6, 2013

    Report

    Report Number
    2024168-2013-01306
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT WAS REPORTED THAT THE DEVICE WAS USED IN A MILDLY CALCIFIED VESSEL. THE STARCLOSE INSTRUCTIONS FOR USE STATES: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - INDICATION FOR USE. THE STARCLOSE SE INSTRUCTIONS FOR USE UNDER PRECAUTIONS STATE: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE STARCLOSE SE DEVICE AFTER A CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING THUMB ADVANCEMENT THE EXCHANGE SHEATH WAS SHEARING AWAY. THE DEVICE WAS REMOVED; THE REPORTER DOESN'T KNOW IF THE SAFETY RELEASE MECHANISM WAS USED OR WHAT STEPS WERE PERFORMED TO REMOVE THE DEVICE FROM THE PATIENT. THE REPORTER ONLY KNEW THAT THERE WAS NO DIFFICULTY REMOVING THE DEVICE. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE 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
    94792 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30107K1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SHEATH: 6 FR, ANGIOMAX