BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2140062 · Received June 25, 2011

    Report

    Report Number
    2024168-2011-04483
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE UNUSED STERILE PROGLIDE DEVICE WITH THE SAME LOT NUMBER, 940016H, AS THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE COMPLAINT DEVICE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4) DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE THREE PERCLOSE PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. A SPECIFIC MODE OF DEVICE FAILURE WAS NOT REPORTED IN THIS CASE. CONTRIBUTING FACTORS TO THE DEVICE NOT WORKING PROPERLY INCLUDES, BUT IS NOT LIMITED TO, PATIENT ANATOMY, USER TECHNIQUE, OPERATIONAL CONTEXT AND MANUFACTURING. THE INFORMATION PROVIDED BY THE CUSTOMER IS LIMITED AND DOES NOT ALLOW FOR ASSIGNING A PROBABLE CAUSE TO THE EXPERIENCED EVENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER SIMILAR INCIDENT REPORTED FROM THIS LOT. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO DEPLOY THE PERCLOSE PROGLIDE SUTURES USING A PRECLOSE TECHNIQUE IN LEFT AND RIGHT COMMON FEMORAL ARTERY BEFORE AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, TWO DEVICES WERE ATTEMPTED ON THE RIGHT SIDE AND TWO DEVICES ON THE LEFT. ALL FOUR DEVICES DID NOT WORK WHEN THEY WERE BEING DEPLOYED. SUBSEQUENTLY, PROLENE SUTURES WERE USED AND DEPLOYED BEFORE THE AAA. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS PROFICIENT IN THE USE OF THE DEVICE. 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 940016H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SHEATH: 7F