BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 6156811 · Received December 8, 2016

    Report

    Report Number
    2024168-2016-08731
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 8, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULT TO REMOVE THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON PROCEDURE CIRCUMSTANCE. THE REPORTED FOOT RETRACTION PROBLEM AND DIFFICULT TO REMOVE THE DEVICE APPEARS TO BE RELATED TO INTERACTION WITH THE PATIENT TISSUE. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A PERIPHERAL INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PROGLIDE FOOT WOULD NOT RETRACT (PARK), WHICH RESULTED IN DIFFICULTY REMOVING THE PROGLIDE DEVICE FROM THE ANATOMY. THE NICK AND SPREAD WAS WIDENED ENOUGH TO REMOVE THE PROGLIDE DEVICE. THE SHEATH WAS UPSIZED TO AN 8F AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. ALTHOUGH THERE WAS NO MALFUNCTION OR ISSUE WITH THE 2ND PROGLIDE, THE PHYSICIAN ALSO CHOSE TO USE A NON-ABBOTT BIOABSORBABLE ANCHOR AND COLLAGEN SPONGE DEVICE AS AN ADJUNCT. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN WAS 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
    804519 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 6083142 08717648013089

    Patients

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