BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2991498 · Received March 6, 2013

    Report

    Report Number
    2024168-2013-01301
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICES ARE FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS. REPORTEDLY THE COMMON FEMORAL ARTERY WAS MILDLY CALCIFIED. THE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE.

    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.

    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 CALCIFIED LEFT COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING DEPLOYMENT OF THE INITIAL PROGLIDE DEVICE, WHEN THE NEEDLE PLUNGER WAS REMOVED NO SUTURE WAS PRESENT ON THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT WITH THE SAME RESULTS WHEN THE NEEDLE PLUNGER WAS REMOVED NO SUTURE WAS PRESENT ON THE NEEDLES. IT WAS BELIEVED THAT THE MILD VESSEL CALCIFICATION WAS CAUSING THE NEEDLES TO DEFLECT. TWO ADDITIONAL PROGLIDES DEVICES WERE SEQUENTIALLY DEPLOYED 60 DEGREES OPPOSITE IN ORIENTATION AND SET TO THE SIDE. THE ACCESS SITE WAS DILATED TO 18-FRENCH TO MATCH THE OUTER DIAMETER OF THE DELIVERY CATHETER. AFTER CONCLUSION OF THE AAA REPAIR PROCEDURE, THE KNOTS FROM THE TWO PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED TO THE ARTERIOTOMY SITE AND TIGHTENED, BUT BLEEDING CONTINUED. LEAVING THE SUTURES IN THE VESSEL, TWO ADDITIONAL PROGLIDE DEVICE SUTURES WERE DEPLOYED TO SUCCESSFULLY ACHIEVE COMPLETE 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
    95973 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention SHEATHS: 6-FRENCH, 18-FRENCH, HEPARIN