BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2111680 · Received June 2, 2011

    Report

    Report Number
    2024168-2011-03838
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 OTHER 7 PROGLIDE DEVICES ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS. A CUFF MISS CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT BECAUSE OF INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE PLUNGER OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. A SUTURE BREAK CAN BE CAUSED BY TOO MUCH TENSION APPLIED, OR THE SUTURE WAS NICKED. THESE MAY HAVE BEEN CONTRIBUTING FACTORS TO THIS EVENT, BUT CANNOT BE CONFIRMED. ULTIMATELY, THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, IN-PROCESS TESTING OF DEVICES ARE PERFORMED TO ASSURE THERE IS NO NEEDLE DEFLECTION, WHICH MAY CAUSE A CUFF MISS. SAMPLINGS OF SUTURES ARE ALSO TESTED UNDER STRESS FOR DIAMETER MEASUREMENTS BEFORE RELEASE TO MANUFACTURING TO ENSURE SUTURES MEET STRENGTH REQUIREMENTS. A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. IT SHOULD BE NOTED THAT THE REPORTED HEAVY CALCIFICATION OF THE ARTERY MAY HAVE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, BUT COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE PRODUCT RETURNED FOR EXAMINATION, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE THROUGH AN 8FR SHEATH THEN UP SIZED TO A 19 OR 22FR SHEATH DURING AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING THE PRE-CLOSE TECHNIQUE EITHER A CUFF MISS, A FRAYED SUTURE OR A SUTURE BREAK OCCURRED. THE PHYSICIAN USED 2 PROGLIDE DEVICES EACH DURING THE PRE-CLOSE TECHNIQUE FOR A TOTAL OF 8 PROGLIDES. HEMOSTASIS WAS ACHIEVED USING AN ADDITIONAL 2 PROGLIDE DEVICES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, 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 020376H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8FR, 19-22FR