BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2760939 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06073
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF BROKEN HANDLE COULD NOT BE CONFIRMED, BUT THE EFFECTS OF THE OBSERVED HOLDER SHAFT DETACHED FROM THE NEEDLE HOLDER COULD HAVE APPEARED AS A BROKEN HANDLE TO THE USER AND THIS LED TO FAILURE TO DEPLOY THE NEEDLES, AS REPORTED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT-HANDLING DATABASE INDICATED THERE ARE NO SIMILAR INCIDENTS REPORTED FROM THIS LOT FOR THIS DEFICIENCY. OVERALL, RECORD REVIEW DEMONSTRATES THAT THIS ISSUE IS ISOLATED AND DOES NOT AFFECT A LARGER POPULATION OF DEVICES. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED PER LOCAL QUALITY SYSTEM PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED WITH THE PROSTAR XL IN THE LEFT COMMON FEMORAL ARTERY USING THE PRE-CLOSURE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. THE ARTERIOTOMY WAS 18 FR AND THE VESSEL WAS DESCRIBED AS NOT CALCIFIED AND NOT TORTUOUS. REPORTEDLY, DURING NEEDLE DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO PULL THE HANDLE AWAY FROM THE HUB TO DEPLOY THE NEEDLES BUT THE HANDLE BROKE. THE NEEDLES COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED AND A SECOND PROSTAR XL WAS DEPLOYED WITHOUT COMPLICATION AND THE SUTURES WERE SET ASIDE FOR THE TAVI PROCEDURE. THE SHEATH SIZE REMAINED AS 18 FR TO PERFORM THE INDEX PROCEDURE. AFTER COMPLETION OF THE INDEX PROCEDURE HEMOSTASIS WAS ACHIEVED WITH THE DEPLOYED PROSTAR XL SUTURES. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROSTAR XL DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20604K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 18 FR.HEPARIN