BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3872180 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03811
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED NEEDLE TO CUFF MISS AND FOOT BREAK WERE CONFIRMED. BASED ON VISUAL 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-CONFORMING MATERIAL REPORTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE TWO ADDITIONAL PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED WITH THREE PROGLIDE DEVICES USING THE PRECLOSE TECHNIQUE IN THE RIGHT COMMON FEMORAL ARTERY (RCFA) PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, A CUFF MISS AND FOOT BREAK OCCURRED WITH ALL THREE PROGLIDE DEVICES. TWO ADDITIONAL PROGLIDE SUTURES WERE PRE-PLACED SUCCESSFULLY USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS 6F AND THE SHEATH WAS UPSIZED TO 17F FOR THE AAA PROCEDURE. THE AAA PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED WITH THE TWO SUCCESSFULLY PRE-PLACED SUTURES. AN ANGIOGRAM WAS TAKEN AND SHOWED NO EVIDENCE OF ANY PIECES LEFT BEHIND FROM THE REPORTED FOOT BREAKS. 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 AND ESTABLISHED WITH THE PRECLOSE DEPLOYMENT TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349913 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40220K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 17F, HEPARIN