BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3242802 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04608
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE 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 PHYSICIAN USED 2 PROGLIDES TO CLOSE THE 10F ARTERIOTOMY OF THE RCFA WITH SUCCESS. THIS WAS FOLLOWED BY A SHORT BALLOON INFLATION SUPERIOR TO THE PUNCTURE SITE (APPROXIMATELY 20 MINUTES). FURTHER ANGIOGRAPHY SHOWED THAT HEMOSTASIS WAS ACHIEVED. NO EXTRAVASATION OF CONTRAST WAS OBSERVED AND THE 10F WAS PARTIALLY OCCLUSIVE. AT THIS POINT THE PATIENT WAS EXHIBITING ARTERIAL HYPOTENSION. THE PHYSICIAN USED 2 PROGLIDES TO CLOSE THE 10F ARTERIOTOMY OF THE RCFA WITH SUCCESS. THIS WAS FOLLOWED BY A SHORT BALLOON INFLATION SUPERIOR TO THE PUNCTURE SITE (APPROXIMATELY 20 MINUTES). FURTHER ANGIOGRAPHY SHOWED THAT HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS TRANSFERRED TO THE ICU FOR CARE AND MONITORING. THE PATIENT DIED AT ABOUT 01:30, APPROXIMATELY 6 HOURS AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WHO ARE MORBIDLY OBESE (BODY MASS INDEX GREATER THAN 40 KG/M). THE DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER TWO PERCLOSE PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY (RCFA) WAS ATTEMPTED USING A PROGLIDE DEVICE, WITH A 5FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AN UNUSUAL NOISE WAS HEARD DESCRIBED AS "HOLLOW AND NOT THE USUAL STRONG SOUND. IT FELT UNUSUAL AND BELIEVED THE SUTURES HAD NOT BEEN CAPTURED, THERE WAS NO FEELING OF SETTLING IN AS I WOULD NORMALLY EXPECT". THE PROGLIDE FOOT WAS PARKED AND THE DEVICE EXITED THE ARTERIOTOMY WITH NO TROUBLE. ON CROSSING THE SKIN, DESCRIBED AS "THICK AND TOUGH", IT WAS DIFFICULT FOR THE FOOT SECTION TO CROSS AND TOOK A LOT OF EFFORT AND MANIPULATION. ONCE THE FOOT SECTION CROSSED THE SKIN IT WAS NOTICED THAT A PORTION OF THE FOOT WAS BROKEN AND HANGING SEPARATE THOUGH STILL ATTACHED, DESCRIBED AS "HANGING OFF". A PIECE OF ARTERIAL TISSUE WAS ATTACHED TO THE FOOT. DURING THIS TIME THE PATIENT WAS BLEEDING FROM THE ARTERIOTOMY SITE AND A 10F SHEATH WAS CHOSEN DUE TO THE AMOUNT OF BLEEDING AND DUE TO THE FACT THAT A PIECE OF "ARTERIAL TISSUE" WAS SEEN ON THE DEVICE. THE PHYSICIAN GAINED CONTRA-LATERAL ACCESS VIA THE LEFT COMMON FEMORAL ARTERY (LCFA) SO THAT AN ASSESSMENT OF THE RCFA COULD BE MADE. RCFA ANGIOGRAPHY SHOWED A MARGINALLY HIGH PUNCTURE (JUST BELOW THE TOP OF THE FEMORAL HEAD), BUT BELOW THE LOWER BORDER OF THE INFERIOR EPIGASTRIC ARTERY. THE PHYSICIAN BELIEVES THIS RESULTED IN A RELATIVELY SHALLOW PUNCTURE WHICH MAY HAVE CONTRIBUTED TO THE PROGLIDE NOT WORKING DUE TO A SHALLOW DEPLOYMENT ANGLE. NO EXTRAVASATION OF CONTRAST WAS OBSERVED AND THE 10F WAS "PARTIALLY OCCLUSIVE". AT THIS POINT THE PATIENT WAS EXHIBITING ARTERIAL HYPOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342401 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R SHEATH: 5F