BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2212216 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05746
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. IT WAS REPORTED THAT THE PROGLIDE DEVICES WERE USED IN A HEAVILY CALCIFIED VESSEL. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE COMPLETED; HOWEVER, INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCE WAS NOT RETURNED FOR ANALYSIS. THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE COMPLAINT. A CUFF MISS CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO MANUFACTURING, USER TECHNIQUE, OR ANATOMICAL CONDITIONS. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. USER TECHNIQUE, SUCH AS, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL MAY CONTRIBUTE TO A CUFF MISS. PATIENT ANATOMICAL CONDITIONS(E.G. HEAVILY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) MAY CONTRIBUTE TO A CUFF MISS. A FEMORAL ANGIOGRAM WAS TAKEN SHOWING HEAVY CALCIFICATION. THE PROGLIDE INSTRUCTIONS FOR USE, STATES: THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. A CONCLUSIVE CAUSE FOR THE REPORTED CUFF MISS, WHICH RESULTED IN HEMORRHAGING, REQUIRED ADDITIONAL CLOSURE DEVICE AND THERAPY/NON-SURGICAL TREATMENT TO ACHIEVE HEMOSTASIS, COULD NOT BE DETERMINED. HOWEVER, THE REPORTED CALCIFICATION OF THE ARTERY MAY HAVE PLAYED A ROLE IN THE REPORTED CUFF-MISS. A REVIEW OF THE LOT HISTORY RECORD AND A QUERY OF THE COMPLAINT HANDLING DATABASE WERE NOT PERFORMED BECAUSE THE DEVICE LOT NUMBER WAS NOT REPORTED. BASED ON THE REVIEW OF THE EVENT INFORMATION AND TESTING/INSPECTION CRITERIA FOR THIS DEVICE, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER A CAROTID ARTERY STENTING PROCEDURE USING A 6F SHEATH. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. ADDITIONAL INFORMATION WAS NOT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F