BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2992594 · Received March 7, 2013

    Report

    Report Number
    2024168-2013-01311
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 19, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS 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.

    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 THE RIGHT COMMON FEMORAL ARTERY WAS MODERATELY CALCIFIED. 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 DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER TWO PROGLIDE DEVICES REFERENCED, WILL BE REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE MODERATELY CALCIFICATION RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6FR SHEATH AFTER AN ANGIOPLASTY INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE PLUNGER WAS DEPRESSED AND THEN RETRACTED IT WAS NOTICED THAT THE SUTURE END WAS NOT PRESENT, ONLY THE LINK. A CUFF MISS OCCURRED. THE ARTERY WAS RE-WIRED AND A SECOND PROGLIDE DEVICE WAS USED ROTATING SLIGHTLY TO THE LATERAL SIDE AND AGAIN A CUFF MISS OCCURRED. THE ARTERY WAS RE-WIRED AND A THIRD PROGLIDE DEVICE WAS USED ROTATING SLIGHTLY TO THE MEDIAL SIDE BUT AGAIN WITH THE SAME RESULTS. THE PHYSICIAN REPORTEDLY WAS AWARE OF THE CALCIFICATION ON THE ANTERIOR WALL OF THE COMMON FEMORAL ARTERY BUT HAS USED THE ABOVE STRATEGY IN THE PAST AND ACHIEVED GOOD RESULTS. THE ARTERY WAS AGAIN RE-WIRED AND A NON-ABBOTT DEVICE AND MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97460 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21112J1

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention SHEATH: 6F HEPARIN