BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1984323 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00807
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT ONLY THE CLIP WAS RETURNED. THE CLIP WAS RETURNED BROKEN AT A LOOP ADJACENT TO ONE OF THE LONG TINES. THE REPORTED EXPERIENCE IS CONFIRMED. THE INSPECTION RECORDS FOR THE CLIP LOT WERE REVIEWED AND THE LOT WAS TESTED AND PASSED. BASED ON THE INSPECTION CRITERIA AND THE REPORTED EVENT, THE REPORTED BREAK MOST LIKELY OCCURRED DURING REMOVAL FROM THE SKIN. THE REPORT OF NOT MAKING A PROPER NICK AND SPREAD IS CONSISTENT WITH THE CLIP BEING DEPLOYED AT SKIN LEVEL. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE CLIP DEPLOYING AT SKIN LEVEL IS DUE TO THE OPERATION CONTEXT DURING USE OF THE DEVICE. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE HAS BEEN RETURNED. INVESTIGATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, IT WAS REPORTED THAT THE ACCESS SITE WAS THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. THE PHYSICIAN STATED THAT HE MAY NOT HAVE MADE AN ADEQUATE NICK AND SPREAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE CLIP DEPLOYED ON THE LEVEL OF THE SKIN. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 930066H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention