BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2861807 · Received December 7, 2012

    Report

    Report Number
    2024168-2012-07726
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE PROGLIDE DEVICE WAS REPORTEDLY DEPLOYED IN A HEAVILY CALCIFIED COMMON FEMORAL ARTERY. THE INSTRUCTIONS FOR USE STATES IN THE SPECIAL PATIENT POPULATIONS SECTION 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED LOSS OF ARTERIAL ACCESS WAS CONFIRMED AS ANALYSIS OF THE DEVICE INDICATED THAT THE POSTERIOR PORTION OF THE FOOT HAD BROKEN OFF, MOST LIKELY DURING FOOT DEPLOYMENT REDUCING THE PROFILE OF THE FOOT BY HALF ALLOWING IT TO BE PULLED OUT DURING DEVICE RETRACTION. THE DETACHED PORTION OF THE FOOT WAS NOT RETURNED. THE REPORTED FAILURE OF THE POSTERIOR PORTION OF THE FOOT TO DEPLOY COULD NOT BE CONFIRMED AS THE ANALYSIS OF THE DEVICE INDICATED THE POSTERIOR PORTION OF THE FOOT WAS BROKEN DURING DEPLOYMENT IN CHALLENGING ANATOMY. BASED ON VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SUPERFICIAL FEMORAL ARTERY INTERVENTION, VIA CONTRA-LATERAL APPROACH, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF A HEAVILY CALCIFIED LEFT COMMON FEMORAL ARTERY USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, AFTER LIFTING THE LEVER TO DEPLOY THE FOOT, WHEN THE DEVICE WAS PULLED BACK TO PLACE THE FOOT AGAINST THE ANTERIOR SURFACE OF THE ARTERY WALL, THE DEVICE PULLED OUT OF THE VESSEL. WHEN THE DEVICE WAS REMOVED IT APPEARED THAT THE POSTERIOR PORTION OF THE FOOT DID NOT FULLY DEPLOY. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. AFTER ARTERIOTOMY CLOSURE, THE LEFT FEMORAL AND DISTAL PULSES WERE PALPABLE AND WERE REPORTED TO REMAIN UNCHANGED. 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20816J1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SHEATH: 7-FRENCH COOK ARROW. HEPARIN