BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2853186 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07589
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 16, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE 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. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNED. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE WAS RETURNED FOR EVALUATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. BECAUSE ALL RELATED COMPONENTS WERE NOT RETURNED WITH THE DEVICE, THE SCOPE OF THIS INVESTIGATION WAS VERY LIMITED AND THE REPORTED CUFF MISS 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH FILED, USER FACILITY SUMMARY REPORT (REPORT #(B)(4)) 2 OF 3 PAGES RECEIVED: DESCRIBE THE EVENT PROBLEM]: "PERCLOSE PROGLIDE WAS ATTEMPTED X2 BUT THIS RESULTED IN FAILURE TO CAPTURE AND PULL SUTURES THROUGH. ULTIMATELY, PLACEMENT OF AN ANGIO-SEAL 8-FRENCH SYSTEM WAS EXECUTED WITHOUT DIFFICULTY AND HEMOSTASIS ACHIEVED." WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: "RETROGRADE LEFT HEART CATHETERIZATION, SELECTIVE CORONARY ANGIOGRAPHY; LEFT VENTRICULAR ANGIOGRAPHY; ANGIOGRAPHY OF THE RIGHT FEMORAL ARTERY WITH ATTEMPTED PERCLOSE. THIS HAS FAILED AND ULTIMATELY HEMOSTASIS ACHIEVED WITH ANGIO-SEAL DEVICE." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20928J1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention