BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3843439 · Received June 2, 2014

    Report

    Report Number
    2024168-2014-03512
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED FAILURE TO DEPLOY COULD NOT BE CONFIRMED. DURING THE DEVICE ANALYSIS, THE HANDLE WAS PULLED STRAIGHT OUT TO DEPLOY THE NEEDLES WITHOUT DIFFICULTY. ALL FOUR (4) NEEDLES EMERGED FROM THE HUB. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. A QUERY OF THE COMPLAINT HISTORY OF THE REPORTED LOT 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 SUTURE PLACEMENT WITH A PROSTAR XL DEVICE WAS ATTEMPTED IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. THE ARTERIOTOMY WAS AN 18F. REPORTEDLY, DURING THE PRE-PLACEMENT OF THE SUTURES, THE HUB AND BARREL ON THE DEVICE WOULD ROTATE; HOWEVER, THE HANDLE COULD NOT BE PULLED BACK AND THE NEEDLES STAYED WITH THE SYSTEM. THE DEVICE WAS REMOVED AND A SECOND PROSTAR XL DEVICE WAS USED. THE TAVI PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED SUTURES OF THE PROSTAR XL DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROSTAR DEVICE AND ESTABLISHED IN THE PRE-CLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322123 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31119K1

    Patients

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