BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2904879 · Received January 9, 2013

    Report

    Report Number
    2024168-2013-00174
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL 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. IT WAS REPORTED THAT THE PATIENT WAS MORBIDLY OBESE. THE INSTRUCTIONS FOR USE STATES: THE SAFETY AND EFFECTIVENESS OF THE PROSTAR XL 10F PVS SYSTEM HAS NOT BEEN ESTABLISHED IN PATIENTS WHO ARE MORBIDLY OBESE WHERE LESS THAN ONE THIRD OF THE ACCESS NEEDLE IS ABOVE THE SKIN LINE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT IS NOTED TO BE MORBIDLY OBESE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER PROSTAR DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROSTAR DEVICE AFTER A TRANSLUMINAL AORTIC VALVE IMPLANTATION INTERVENTIONAL PROCEDURE. REPORTEDLY, THE NEEDLES WOULD NOT EJECT (DEPLOY) THROUGH THE VESSEL WALL. A SECOND PROSTAR DEVICE WAS INSERTED BUT THE NEEDLES DID NOT DEPLOY COMPLETELY BECAUSE OF TANGLED THREADS (SUTURE LUMEN). HEMOSTASIS WAS ACHIEVED SURGICALLY. THE PROCEDURE WAS PROLONGED FOR TWO HOURS. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12347 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20611K1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SHEATH: 18F