BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2151939 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04787
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. ULTIMATELY, THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE PRODUCT EXPERIENCE. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT THE RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, SAMPLINGS OF FINISHED DEVICES ARE TESTED TO VERIFY FUNCTIONALITY OF THE DEVICE. A STARCLOSE SE DEVICE CAN BE DIFFICULT TO REMOVE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO MANUFACTURING, TISSUE COMPACTION THAT RESULTS IN DISTAL FORCE BEING APPLIED TO THE LOCATOR WINGS BENDING THEM DISTALLY, AND RESTRICTING THEIR PROPER RETRACTION INTO THE CLIP DELIVERY TUBESET. THIS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE PRODUCT EXPERIENCE, BUT COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENT REPORTED FOR THIS LOT. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA, AND A REVIEW OF THE LOT HISTORY RECORD THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO A 100% INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    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 PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN UNSPECIFIED CATHERIZATION PROCEDURE THROUGH A 6F SHEATH, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF THE FEMORAL ARTERY WITH A STARCLOSE SE DEVICE. REPORTEDLY, DURING THUMB ADVANCER DEPLOYMENT, RESISTANCE WAS FELT AND DEPLOYMENT COULD NOT BE COMPLETED. THE DEVICE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THOUGH REQUESTED, 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 920236H

    Patients

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