BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2870310 · Received December 12, 2012

    Report

    Report Number
    2024168-2012-07866
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULT THUMB ADVANCER DEPLOYMENT WAS CONFIRMED. THE PROBABLE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPROPER OR INCORRECT PROCEDURE OR METHOD, AGAINST RESISTANCE. PER INSTRUCTIONS FOR USE: UNDER CLOSURE PROCEDURE - DO NOT ADVANCE THE THUMB ADVANCER AGAINST EXCESSIVE RESISTANCE. IF EXCESSIVE RESISTANCE IS EXPERIENCED DURING ADVANCEMENT OF THE THUMB ADVANCER, MANUALLY COLLAPSE THE LOCATOR WINGS AND REMOVE THE DEVICE. 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 THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE WITH A 6FR SHEATH, AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, UPON PUSHING THE PLUNGER DOWN RESISTANCE WAS FELT DISTAL 1CM. WHEN THE BUTTON WAS PRESS TO DEPLOY THE CLIP, IT WAS FELT IT DID NOT CLICK CORRECTLY. THE LOCATION OF THE CLIP REMAINS IN THE ARTERY. THE STARCLOSE SE WAS REMOVED WITH NO DIFFICULTLY. COMPLETE CLOSURE DID NOT OCCUR AND MANUAL ARTERIAL COMPRESSION WAS APPLIED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. 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 20821K1

    Patients

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