BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3820606 · Received May 20, 2014

    Report

    Report Number
    2024168-2014-03190
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    March 21, 2014
    Report Date
    May 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 COULD NOT BE COMPLETED. A REVIEW 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 EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE. (B)(4): AGAINST RESISTANCE. PER THE INSTRUCTIONS FOR USE, DO NOT USE EXCESSIVE FORCE OR REPEATEDLY PUSH THE PLUNGER ASSEMBLY. EXCESSIVE FORCE ON THE PLUNGER DURING DEPLOYMENT COULD POTENTIALLY CAUSE BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTION AND/OR SURGICAL REMOVAL OF THE DEVICE AND VESSEL REPAIR. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE WITH A 5FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN ATTEMPTING TO DEPLOY THE NEEDLES THE PLUNGER WOULD GO ONLY HALF WAY DOWN. PRESSURE WAS APPLIED; HOWEVER, THE PLUNGER WOULD STILL NOT GO DOWN. WHEN ATTEMPTING TO REMOVE THE DEVICE IT GOT STUCK IN THE PATIENT ANATOMY. THE WHITE SUTURE WAS CUT AND THE DEVICE WAS ABLE TO BE REMOVED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE TECHNICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300234 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SHEATH: 5FR