BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2894045 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00012
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FEMORAL ANGIOGRAM NOT TAKEN. THE PROGLIDE INSTRUCTIONS FOR USE STATES: PERFORM A FEMORAL ANGIOGRAM THROUGH THE INTRODUCER SHEATH TO VERIFY THAT THE ACCESS SITE IS IN THE COMMON FEMORAL ARTERY. TO AVOID POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY, FLUOROSCOPICALLY EVALUATE THE FEMORAL ARTERY FOR SIZE, CALCIUM, TORTUOSITY, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED CLIP DEPLOYED AT DISTAL PART OF THE SHEATH WAS CONFIRMED, AND IT WAS A RESULT OF AN ELONGATED/STRETCHED SHEATH DURING USE. BASED ON VISUAL AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE WAS NO PRODUCT DEFICIENCY OBSERVED. REPORTEDLY, A FEMORAL ANGIOGRAM WAS NOT TAKEN PRIOR TO THE PROCEDURE, AS OUTLINED IN THE STARCLOSE SE INSTRUCTIONS FOR USE, AND IT IS POSSIBLE THAT NOT PERFORMING THIS STEP COULD HAVE INFLUENCED THE REPORTED EVENT; HOWEVER, THIS CANNOT BE CONFIRMED. THE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE MOST LIKELY RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. 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 INDICATED DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. FOUR UNUSED STERILE STARCLOSE SE DEVICES WITH SAME LOT NUMBER THAN THE COMPLAINT DEVICE ((B)(4)) WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES MET MANUFACTURING CRITERIA. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES.

    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 DEVICE AFTER A NEURO DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT THE DEVICE WAS REMOVED AND THE CLIP WAS OBSERVED AT THE DISTAL PART OF THE SHEATH, 5MM FROM THE SHEATH EXIT. NO PARTS LEFT IN THE PATIENT. MANUAL ARTERIAL COMPRESSION WAS USED FOR APPROXIMATELY 10 MINUTES 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
    2155 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 20808K1

    Patients

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