BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3882264 · Received June 18, 2014

    Report

    Report Number
    2024168-2014-03921
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULT TO INSERT GUIDE WIRE WAS CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULT TO INSERT GUIDE WIRE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: SHEATH: 6F; GUIDE WIRE: J 0.035, TEFLON 0.035, HYDROPHIL, TERUMO 0.035; HEPARIN. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE FILING OF THE INITIAL MEDWATCH MFR REPORT ADDITIONAL INFORMATION WAS RECEIVED: THE PHYSICIAN WAS NOT TRAINED IN THE USE OF THE PROSTAR XL DEVICE. ANOTHER PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE WAS PRESENT DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROSTAR XL DEVICE WITH A 6F SHEATH AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER EXTRACTION OF THE PROSTAR NEEDLES AND BEFORE REMOVAL OF THE PROSTAR DEVICE, THERE WAS A FAILURE TO INSERT A J 0.035 GUIDEWIRE IN THE PROSTAR 10F. A SECOND ATTEMPT WAS DONE WITH A GUIDE WIRE TEFLON J .035 AND IT COULD NOT BE INSERTED. ANOTHER GUIDE WIRE, HYDROPHILE TERUMO 0.035 CURVED, WAS USED AND COULD BE INSERTED IN THE PROSTAR. THE PROSTAR XL DEVICE SUCCESSFULLY ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT IS UNKNOWN IF THE PHYSICIAN IS 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
    358696 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40310K1

    Patients

    Seq Age Sex Outcome Treatment
    1