BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3903214 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04226
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DRIED BLOOD WAS OBSERVED THROUGHOUT THE DEVICE. ALSO, THERE WAS EXCESSIVE DRIED BLOOD OBSERVED WITHIN THE MARKER TUBE. THIS OBSERVATION INDICATED THAT THE DEVICE WAS INTRODUCED INTO THE PATIENT ANATOMY AND ARTERIAL BLOOD MARKING WAS ACHIEVED. THEREFORE, THE REPORTED UNSUCCESSFUL ARTERIAL BLOOD MARKING COULD NOT BE CONFIRMED. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING 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 INDICATED THERE HAD BEEN NO SIMILAR UNSUCCESSFUL ARTERIAL BLOOD MARKING INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A DIAGNOSTIC ANGIOGRAM. REPORTEDLY, AFTER DEVICE INSERTION IN A VERY LARGE PATIENT HAVING A LARGE APRON OF TISSUE AROUND THE ABDOMEN, NO PULSATILE BLOOD FLOW WAS SEEN. THE DEVICE WAS PULLED BACK SLIGHTLY AND THE ANGLE WAS ALTERED, STILL NO PULSATILE BLOOD FLOW. A FEMORAL FLUOROSCOPY WAS TAKEN PRIOR TO REMOVAL AND THE PROGLIDE SHEATH WAS NOT KINKED AND APPEARED TO BE INSIDE ARTERY. A NON- ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. 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
    381154 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30927K1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SHEATH: 6F