BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3123903 · Received May 22, 2013

    Report

    Report Number
    2024168-2013-03216
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, THE REPORTED FAILURE TO DEPLOY THE NEEDLES COULD NOT BE CONFIRMED AND A PROBABLE CAUSE COULD NOT BE IDENTIFIED. 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 FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ATTEMPTED SUTURE PLACEMENT IN THE LEFT AND RIGHT COMMON FEMORAL ARTERIES USING THE PRECLOSE TECHNIQUE PRIOR TO AN THORACIC ABDOMINAL AORTIC ANEURYSM PROCEDURE (AAA). THE ARTERIOTOMY WAS 8FR AND DURING THE AAA PROCEDURE THE SHEATH WAS UPSIZED TO A 9FR AND 18FR SHEATH. REPORTEDLY, DURING DEPLOYMENT OF THE NEEDLES, THE NEEDLES CAME OUTSIDE OF THE BARREL. A SURGICAL CUT DOWN WAS REQUIRED FOLLOWING THE AAA PROCEDURE TO CLOSE THE LEFT COMMON FEMORAL ARTERY. REPORTEDLY, FOLLOWING DEPLOYMENT, EFFECTIVE CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY, WITH A PERCLOSE PROGLIDE DEVICE WAS UNSUCCESSFUL AND A CUT DOWN WAS PERFORMED TO CLOSE THE RIGHT COMMON FEMORAL ARTERY. AN 8FR SHEATH WAS USED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE AND PROSTAR XL DEVICE, AS WELL AS TRAINED IN THE PRECLOSE TECHNIQUE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226012 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21114K1

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention SHEATH: 8F, 9F, 18F HEPARIN