BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3223040 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04344
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 3, 2013
    Report Date
    June 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    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). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PROSTAR XL DEVICES WERE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED IN THE NEEDLE BACK-DOWN POSITION. BECAUSE THE NEEDLES AND SUTURES WERE NOT RETURNED WITH THE DEVICE, THE SCOPE OF THIS INVESTIGATION WAS LIMITED AND THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED. BASED ON VISUAL INSPECTION 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN UNSPECIFIED PROCEDURE IN THE OPERATING ROOM, ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING THREE PROSTAR XL DEVICES. REPORTEDLY, EACH OF THE THREE PROSTAR XL DEVICES DID NOT DEPLOY CORRECTLY. IT WAS NOT SPECIFIED HOW HEMOSTASIS WAS ACHIEVED. IT WAS NOT SPECIFIED IF THE OPERATOR WAS 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
    322237 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21010K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention