BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3000265 · Received March 12, 2013

    Report

    Report Number
    2024168-2013-01405
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 14, 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 MILDLY 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. THE OTHER PERCLOSE PROGLIDE DEVICES, REFERENCED ARE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS. PATIENT WEIGHT ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN A MILDLY FIBROTIC AND CALCIFIED LEFT COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING DEPLOYMENT OF THE INITIAL TWO PROGLIDE DEVICES THROUGH A 6-FRENCH SIZED ACCESS SITE, BOTH INCURRED A NEEDLE-TO-CUFF MISS. BOTH PROGLIDE DEVICES WERE REMOVED AND THE SUTURE FROM TWO ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY DEPLOYED AND SET TO THE SIDE. THE ACCESS SITE WAS UPSIZED TO 20-FRENCH TO ACCOMMODATE THE AAA DELIVERY CATHETER. AFTER CONCLUSION OF THE AAA REPAIR PROCEDURE, THE KNOTS FROM THE TWO PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED, BUT BLEEDING CONTINUED. LEAVING THE SUTURE IN THE VESSEL, TWO ADDITIONAL PROGLIDES WERE DEPLOYED, BUT BLEEDING CONTINUED. HEMOSTASIS WAS ACHIEVED WITH ANOTHER PROGLIDE DEVICE. THE PHYSICIAN WAS REPORTED TO BE IN-TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104052 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATHS: 6-FRENCH, 20-FRENCH HEPARIN