BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3840827 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03457
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - THE INITIAL MEDWATCH REPORT WAS INADVERTENTLY FILED WITH THE PRODUCT PROBLEM BOX CHECKED. REPORTED EVENT IS A SERIOUS INJURY ONLY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS SUCCESSFUL USING A PROGLIDE DEVICE WITH A 5F SHEATH AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE PATIENT FELT PAIN IN THE LEG LATER IN THE EVENING AFTER THE ARTERIOTOMY CLOSURE. A TEAM OF VASCULAR SURGEONS AT A DIFFERENT MEDICAL CENTER OTHER THAN WHERE THE DIAGNOSTIC PROCEDURE HAD BEEN PERFORMED FOUND THAT THROMBOSIS HAD OCCURRED IN THE RIGHT COMMON FEMORAL ARTERY AT THE ACCESS SITE. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) (INFLATION OF THE THROMBOTIC REGION WITH A BALLOON) WAS PERFORMED TO REOPEN THE VESSEL. AFTER THIS INTERVENTION THERE HAVE BEEN NO MORE CONSEQUENCES FOR THE PATIENT. NO CLINICALLY SIGNIFICANT DELAY IN THE DIAGNOSTIC PROCEDURE WAS REPORTED. THE INITIAL PHYSICIAN WHO PERFORMED THE DIAGNOSTIC PROCEDURE IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318030 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S SHEATH: 5F