BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4182353 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06786
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. DATE OF OCCURRENCE IS AN ESTIMATED DATE BECAUSE THE EXACT DATE WAS NOT REMEMBERED OR REPORTED BY THE HOSPITAL. IT WAS REPORTED THAT MILD CALCIFICATION WAS NOTED IN A COMMON FEMORAL ARTERY AT THE ACCESS SITE. 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 OTHER PROGLIDE DEVICE REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED, NEEDLE TO CUFF MISS WAS CONFIRMED. THE OBSERVED LINK DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE AND COULD APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. BASED ON A VISUAL AND FUNCTIONAL INSPECTION 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS RETRACTED A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A THIRD PROGLIDE DEVICE. 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
    662037 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40506K1

    Patients

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