BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2202879 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05683
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE COMPLETED; HOWEVER, INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS THEREFORE A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. AS INDICATED IN THE EVENT INFORMATION, THE ITCHING ON THE PATIENTS LEG AND THE RED BLOTCHY APPEARANCE (RASH ON BOTH LEGS) IS DUE TO AN ALLERGIC REACTION TO THE STARCLOSE SE CLIP. THE STARCLOSE SE VASCULAR CLOSURE SYSTEM INSTRUCTION FOR USE (IFU), STATES THAT THE DEVICE IS CONTRAINDICATED FOR USE IN PATIENTS WITH KNOWN HYPERSENSITIVITY TO NICKEL-TITANIUM. THEREFORE, PATIENTS ANATOMICAL CONDITION IS THE MOST LIKELY CAUSE FOR THE REPORTED HYPERSENSITIVITY THAT REQUIRED TREATMENT WITH MEDICATION. AN IFU VIOLATION HAS NOT OCCURRED BECAUSE THE PATIENT MENTIONED THAT THEY WERE ALLERGIC TO NICKEL POST PROCEDURE. IN THIS CASE, MANUFACTURING AND USER TECHNIQUE COULD NOT HAVE CONTRIBUTED TO THE REPORTED ALLERGIC REACTION BECAUSE THE CLIP WAS SUCCESSFULLY DEPLOYED AND ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE LOT HISTORY RECORD COULD NOT BE REFERENCED FOR ANY NON CONFORMITIES AS THE LOT NUMBER WAS NOT PROVIDED FOR THIS DEVICE.

    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 DEVICE AFTER A RENAL ANGIOPLASTY PROCEDURE. REPORTEDLY, THE PATIENT UNDERWENT A SUCCESSFUL CLOSURE PROCEDURE ON (B)(6) 2011. THREE DAYS LATER ((B)(6) 2011), THE PATIENT RETURNED COMPLAINING OF ITCHING ON HER LEG AND A RED BLOTCHY APPEARANCE (RASH ON BOTH LEGS). ON (B)(6) 2011, THE PATIENT CONTACTED THE PHYSICIAN'S OFFICE AND WAS PRESCRIBED MEDICATION AS PART OF THE TREATMENT. NO OTHER MEDICATION WAS ADMINISTERED. THERE WERE NO OTHER REACTIONS OBSERVED. THE NURSE ALSO PRESCRIBED MEDICATION FOR TOPICAL APPLICATION. THE PATIENT LATER INFORMED THE NURSE OF AN ALLERGY TO NICKEL. THE NURSE WILL BE FOLLOWING UP WITH THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention