BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3070311 · Received April 22, 2013

    Report

    Report Number
    2024168-2013-02466
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - EXPIRATION DATE CHANGED FROM 01/31/2015 TO 03/31/2015. CORRECTION - DEVICE RETURNED ON (B)(4) 2013. CORRECTION - MANUFACTURING DATE CHANGED FROM 01/2013 TO 03/2013. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED CUFF MISS WAS NOT CONFIRMED. THE PLUNGER HAD NOT BEEN DEPRESSED TO DEPLOY THE NEEDLES. BASED ON THE VISUAL INSPECTION 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 THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. ESTIMATED DATE OF OCCURRENCE, EXACT DATE WAS NOT KNOWN. THE OTHER PROGLIDE DEVICE THAT WAS REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NINE UNUSED, STERILE REPRESENTATIVE SAMPLES WITH THE SAME PART NUMBER WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE NINE RETURNED DEVICES AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING ISSUES OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH, AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, NO SUTURE WAS PRESENT WHEN THE PLUNGER WAS PULLED, A CUFF MISS OCCURRED. A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR 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
    172132 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30124J1

    Patients

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