BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2251466 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06361
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    October 27, 2010
    Report Date
    August 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE WHOLE MONOFILAMENT WAS RETURNED LOOSE AND THE POSTERIOR CUFF AND NEEDLE TIP WERE STILL ATTACHED TO THE RAIL END. BASED ON THE INVESTIGATION FINDINGS, THE LINK WAS BROKEN AT THE POSTERIOR CUFF AND COULD APPEAR SIMILAR TO A CUFF MISS. THE LINK CONNECTS THE ANTERIOR NEEDLE TO THE SUTURE; IF THE LINK IS BROKEN FROM THE CUFF, THE SUTURE WILL NOT BE PRESENT DURING PLUNGER WITHDRAWAL AND THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. A LINK BREAK CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO MANUFACTURING, EXCESSIVE TENSION DURING PLUNGER RETRACTION BY AGGRESSIVELY REMOVING THE PLUNGER AND EXCESSIVE FORCE CAN BE CAUSED BY HIGH FRICTION AGAINST THE SUTURE DUE TO CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.). IT WAS REPORTED THAT THE COMMON FEMORAL ARTERY WAS MODERATELY CALCIFIED. THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (IFU) STATE UNDER SPECIAL PATIENT POPULATIONS, THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED, IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE COULD NOT BE DETERMINED. REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE AN INDICATION OF A PRODUCT QUALITY PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE PLASTIC PART WAS PULLED, THE PROLENE SUTURE WAS NOT ATTACHED TO THE METAL SHAFT, CLOSURE COULD NOT BE COMPLETED. THE SAME RESULTS OCCURRED WITH ALL THREE UNITS. AN UNKNOWN CLOSURE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. 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 REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED. A PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS.

    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 860256H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN