BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2193063 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05543
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE DEVICE ANALYSIS, A CAUSE FOR THE REPORTED SUTURE BREAK COULD NOT BE DETERMINED. A SUTURE BREAK CAN BE CAUSED BY A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, USER TECHNIQUE OR PATIENT ANATOMICAL CONDITIONS. A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. THE SUTURE MAY BREAK IF THE USER APPLIES TOO MUCH TENSION WHILE PULLING ON THE LIMB SUTURE. HOWEVER, IT WAS REPORTED THAT THE SUTURES WERE NOT PULLED HARD. NO OTHER INFORMATION ABOUT USER TECHNIQUE WAS PROVIDED. A FEMORAL ANGIOGRAM WAS TAKEN AND NO DISEASE OR SCAR TISSUE WAS NOTED. OTHER ANATOMICAL INFORMATION OR PATIENT MEDICAL HISTORY WAS NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE SUTURES WERE DEPLOYED AND WHEN THEY WERE BEING PULLED TAUT, THE SUTURES BROKE. THE SUTURES WERE NOT PULLED HARD. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE 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 040416H

    Patients

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