BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3153626 · Received June 8, 2013

    Report

    Report Number
    2024168-2013-03558
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    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. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE COMMON FEMORAL ARTERY WAS REPORTEDLY MODERATELY CALCIFIED. THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ACHIEVED IN A MODERATELY CALCIFIED COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES. DURING PRE-CLOSE PLACEMENT INITIAL PROGLIDE SUTURE WAS DEPLOYED LATERALLY SUCCESSFULLY THROUGH A 6-FRENCH SIZED ACCESS SITE, DURING AN ATTEMPT TO DEPLOY THE SECOND PROGLIDE MEDIAL THE SUTURE PULLED OUT FROM THE VESSEL WHEN THE DEVICE WAS RETRACTED AS THE SUTURES DID NOT ENGAGE WITH THE VESSEL, BUT SINCE HE CLOSES OVER THE WIRE HE WAS ABLE TO REMOVE THE DEVICE OVER A GUIDE WIRE AND THE SUTURE OF ANOTHER PROGLIDE DEVICE WAS DEPLOYED AND SET TO THE SIDE. THE ACCESS SITE WAS DILATED TO 8-FRENCH THAN TO 16-FRENCH TO MATCH THE OUTER DIAMETER OF THE DELIVERY CATHETER. AFTER CONCLUSION OF THE EVAR REPAIR PROCEDURE, THE KNOTS FROM THE TWO PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254272 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention SHEATHS: 6-FRENCH, 8-FRENCH, 16-FRENCH