BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2202966 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05686
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. A SUTURE BREAK CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO MANUFACTURING, OR USER TECHNIQUE, WHEN PULLING THE RAIL SUTURE. FURTHERMORE, PATIENT HAD A HISTORY OF TWO PRIOR ARTERIOTOMIES, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. INFORMATION ABOUT USER TECHNIQUE WAS NOT PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED KNOT BREAKING (SUTURE BREAK). WITH RESPECT TO MANUFACTURING, SUTURE STRENGTH IS TESTED AND ADDITIONALLY, A SAMPLING OF UNITS ARE DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. AS THERE IS LIMITED REPORTED INFORMATION AND FOLLOW-UP CLARIFICATION OF EVENT CIRCUMSTANCES, INCLUDING PATIENT ANATOMICAL CONDITIONS AND USER TECHNIQUE, A CONCLUSIVE CAUSE FOR THE REPORTED (SUTURE BREAK)COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS REVEALED NO NONCONFORMING MATERIAL RECORDS FOR THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN SLIDING THE DEVICE OUT OF THE BODY, THE KNOT BROKE. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. A 6FR SHEATH WAS USED DURING INSERTION OF THE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE 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 050366H

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SHEATH: 6F