BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3870577 · Received June 12, 2014

    Report

    Report Number
    2024168-2014-03770
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. THE RETURNED DEVICE ANALYSIS NOTED ONE ANTERIOR CUFF TAB WAS BROKEN AND NOT RETURNED WITH THE DEVICE. CUFF TABS MEASURE ONE ONE-HUNDREDTH (0.01) OF AN INCH SQUARE. DUE TO THE EXTREMELY SMALL SIZE, A MISSING CUFF TAB IS NOT VISIBLE WITHOUT MAGNIFICATION AND WOULD NOT BE NOTED BY THE USER. 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-CONFORMANCES THAT WOULD HAVE CAUSED OR 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 INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE, USING A PRE-CLOSE TECHNIQUE, VIA A 6F SHEATH PRIOR TO AN AORTIC PROSTHESIS PROCEDURE. REPORTEDLY, WHEN THE NEEDLES WERE REMOVED NO SUTURE WAS PRESENT. TWO ADDITIONAL PROGLIDE DEVICES FROM THE SAME LOT (31021K1) WERE USED WITH THE SAME RESULTS. THE SUTURES OF TWO ADDITIONAL PROGLIDE DEVICES FROM A DIFFERENT LOT (30905K1) WERE SUCCESSFULLY PLACED USING THE PRE-CLOSE TECHNIQUE. THE SHEATH WAS UPSIZED TO 20F AND THE AORTIC PROSTHESIS PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED USING THE SUCCESSFULLY PRE-PLACED PROGLIDE SUTURES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRE-CLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT RETURNED DEVICE ANALYSIS OF ONE DEVICE FROM LOT 30905K1 REVEALED A POSTERIOR CUFF MISS HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348002 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31021K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 20F, HEPARIN