BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3803208 · Received May 9, 2014

    Report

    Report Number
    2024168-2014-02974
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 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). IT WAS REPORTED THAT CALCIFICATION WAS NOTED IN A COMMON FEMORAL ARTERY. THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATES THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED WAS CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NON-CONFORMING MATERIAL REPORTS OR EXCEPTIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED IN THE MILDLY CALCIFIED LEFT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM PROCEDURE (AAA). THE ARTERIOTOMY WAS 12FR SHEATH. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. A THIRD AND FOURTH PROGLIDE DEVICE WERE USED FOR SUCCESSFUL SUTURE PLACEMENT. THE AAA PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED USING THE PRE-PLACED SUTURES OF THE TWO PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRE-CLOSE TECHNIQUE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281449 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40130K1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SHEATH: 12FR, HEPARIN