BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2082310 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03303
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE POSTERIOR PORTION OF THE FOOT WAS BROKEN OFF AND WAS NOT RETURNED. A FOOT BREAK HAS THE SAME RESULT AS A CUFF MISS AND PREVENTS SUTURE RETRIEVAL; HOWEVER, BASED THE ANALYSIS THE REPORTED CUFF MISS COULD NOT BE CONFIRMED. THE RETURNED LEVER, BODY, SHEATH, AND GUIDE COMPONENTS WERE WITHIN SPECIFICATIONS. DUE TO THE BROKEN POSTERIOR FOOT THE NEEDLE TRAJECTORY TEST COULD NOT BE PERFORMED. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE MOST PROBABLE CAUSE FOR THE POSTERIOR FOOT BREAK IS RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. A FOOT BREAK CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, PATIENT ANATOMICAL CONDITIONS SUCH AS OBESITY AND CALCIFICATION CAN INTERFERE WITH NEEDLE DEPLOYMENT, CAUSING THE NEEDLE TO DEFLECT AND STRIKE THE FOOT, BREAKING IT, CALCIFICATION OR OTHER BODY MATERIAL TRAPPED UNDER THE FOOT DURING DEPLOYMENT CAN INTERFERE AND MAY BREAK THE FOOT, FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING DEPLOYMENT CAN PUT PRESSURE ON THE FOOT CAUSING IT TO BREAK. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC MANUFACTURING OR PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. 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 020256H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention