BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3790005 · Received May 5, 2014

    Report

    Report Number
    2024168-2014-02800
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - LOT NUMBER CHANGED FROM 309181K1 TO 30918K1. REPORTEDLY, THE SAFETY RELEASE MECHANISM WAS NOT ACTIVATED TO FACILITATE DEVICE REMOVAL FROM THE PATIENT. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR SEPARATION OF THE GUIDE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT WAS REPORTED THAT THE SAFETY RELEASE MECHANISM WAS NOT ACTIVATED TO FACILITATE DEVICE REMOVAL FROM THE PATIENT. THE INSTRUCTIONS FOR USE (IFU), STATES: IF RESISTANCE IS MET UPON REMOVAL OF THE DEVICE, FOLLOW THE STEPS FOR USING THE SAFETY RELEASE MECHANISM IN THE IFU TO FACILITATE DEVICE REMOVAL FROM THE PATIENT. ADDITIONALLY, DO NOT ADVANCE OR WITHDRAW THE STARCLOSE SE VASCULAR CLOSURE DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE STARCLOSE SE DEVICE SHOULD BE AVOIDED, AS THIS MAY LEAD TO SIGNIFICANT VESSEL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTIONAL AND/OR SURGICAL REMOVAL OF THE DEVICE AND VESSEL REPAIR. IT WAS ALSO REPORTED THE DEVICE WAS USED IN A MODERATELY CALCIFIED VESSEL. THE IFU, STATES: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS USED THE MODERATELY CALCIFIED RIGHT COMMON FEMORAL ARTERY. THE INSTRUCTIONS FOR USE, STATES: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. THE DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. 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 MODERATELY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, UPON REMOVAL THE DISTAL TIP METAL PORTION SEPARATED IN TWO PIECES. THE DEVICE WAS NOT DEPLOYED. IT WAS NOT SPECIFIED IF THE SAFETY RELEASE MECHANISM WAS USED TO REMOVE THE DEVICE FROM THE ANATOMY. HEMOSTASIS WAS ACHIEVED BY APPLYING MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION INDICATED THAT THE SAFETY RELEASE MECHANISM WAS NOT ACTIVATED TO FACILITATE DEVICE REMOVAL FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268931 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30918K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention