BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3192364 · Received June 27, 2013

    Report

    Report Number
    2024168-2013-04018
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED FULLY CLIP-DEPLOYED AND THE RETURNED CONDITION SUGGESTED THAT THE CLIP MIGHT HAVE BEEN PULLED OUT ALONG WITH THE DEVICE AND LANDED ON THE SKIN AFTER BEING FIRED. THEREFORE, THE REPORTED PRODUCT EXPERIENCE IS CONFIRMED. THE PROBABLE CAUSE FOR THE DAMAGED LOCATOR WINGS (BENT AND SUBSEQUENTLY BROKEN) IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS WHILE IN THE TISSUE TRACT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND THE WINGS AND EVENTUALLY BREAK THEM DURING FORCEFUL REMOVAL. DAMAGED WINGS COULD INTERFERE WITH THE CLIP PLACEMENT AS REPORTED. 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, FAILURE TO FOLLOW STEPS/INSTRUCTIONS. PER INSTRUCTIONS FOR USE: UNDER CLOSURE PROCEDURE - IT IS NECESSARY TO CREATE A 5-7 MM SKIN INCISION AT THE SHEATH SITE TO ACCOMMODATE THE INSERTION OF THE CLIP DELIVERY TUBE INTO THE TISSUE TRACT. THIS SHOULD BE DONE AT THE BEGINNING OF THE PROCEDURE PRIOR TO THE ADMINISTRATION OF ANTICOAGULANTS AND ANTIPLATELET AGENTS, IF POSSIBLE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. 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 A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP WAS DEPLOYED; HOWEVER, DUE TO AN INADEQUATE NICK AND SPREAD OF THE SKIN AND SUBCUTANEOUS TISSUE, THE CLIP DEPLOYED ON THE SKIN. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. 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
    292494 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30415K1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SHEATH: 6FR