BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3803090 · Received May 9, 2014

    Report

    Report Number
    2024168-2014-02968
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE OTHER PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BODY OF THE PROGLIDE DEVICE WAS NOT RETURNED. A SUTURE MEASURING APPROXIMATELY 19.5 INCHES WAS RETURNED. DUE TO THE LIMITED AMOUNT OF INFORMATION THE REPORTED EVENT COULD NOT BE CONFIRMED. BASED ON THE 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING PROGLIDE DEVICE WITH A 5F SHEATH AFTER A DIAGNOSTIC RENAL ANGIOGRAM. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE DID NOT HAVE A WHITE END SO THE DEVICE COULD NOT BE DEPLOYED. A SECOND PROGLIDE DEVICE WAS USED AND THE DEVICE HAD BLUE AT THE END OF THE WHITE SECTION AND THE DEVICE COULD NOT BE DEPLOYED. HEMOSTASIS WAS ACHIEVED WITH A NON-ABBOTT DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281321 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30515K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 5FR