BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2212221 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05748
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 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

    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. DIFFICULTY IN REMOVING THE DEVICE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, A MANUFACTURING DEFICIENCY, USER TECHNIQUE AND/OR PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, ALL DEVICES ARE VISUALLY TESTED AND A SAMPLING OF FINISHED DEVICES ARE DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. PATIENT ANATOMICAL CONDITIONS SUCH AS, A TIGHT TISSUE TRACT MAY CAUSE THE REPORTED DIFFICULTY IN REMOVING THE DEVICE. TISSUE COMPACTION THAT RESULTS IN A DISTAL FORCE BEING APPLIED TO THE LOCATOR WINGS, BENDING THEM DISTALLY, AND RESTRICTING THEIR PROPER RETRACTION INTO THE DELIVERY TUBESET CAN ALSO CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. HOWEVER, EXCEPT FOR THE ABSENCE OF CALCIFICATION AND A HISTORY OF CORONARY HEART DISEASE, OTHER PATIENT ANATOMICAL CONDITIONS WERE NOT PROVIDED. INFORMATION CONCERNING USER TECHNIQUE WAS NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY IN REMOVING THE DEVICE COULD NOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD AND A QUERY OF THE COMPLAINT HANDLING DATABASE COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE REVIEW OF THE EVENT INFORMATION AND TESTING/INSPECTION CRITERIA FOR THIS DEVICE, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ACHIEVED USING A STARCLOSE SE DEVICE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, AFTER DEPLOYING THE CLIP, DIFFICULTY WAS ENCOUNTERED WHILE REMOVING THE DEVICE. PER THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED AND THE DEVICE WAS REMOVED. HEMOSTASIS WAS ACHIEVED BY THE CLIP. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THOUGH REQUESTED, 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 54 YR Required Intervention SHEATH: 6F