BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3082905 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02652
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OPERATOR NOT TRAINED. PER THE INSTRUCTIONS FOR USE, UNDER CAUTION - THIS DEVICE SHOULD ONLY BE USED BY PHYSICIANS (OR OTHER HEALTHCARE PROFESSIONALS AUTHORIZED BY OR UNDER THE DIRECTION OF SUCH PHYSICIANS) WHO ARE TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAVE BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS 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 INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS SUCCESSFUL USING A PROGLIDE DEVICE IN BOTH THE LEFT AND RIGHT COMMON FEMORAL ARTERIES USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) INTERVENTIONAL PROCEDURE. THE ARTERIOTOMY WAS A 6F. DURING THE AAA PROCEDURE THE SHEATH WAS UPSIZED TO A 18F IN THE LEFT COMMON FEMORAL ARTERY AND A 12F IN THE RIGHT COMMON FEMORAL ARTERY. REPORTEDLY, AFTER THE AAA PROCEDURE DURING THE ARTERIOTOMY CLOSURE A SUTURE BREAK OCCURRED DURING ADVANCING THE KNOT TO THE ARTERIAL SURFACE IN THE LEFT COMMON FEMORAL ARTERY. THE THORACIC SURGEON, WHO IS REPORTED NOT TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE REQUESTED TO CLOSE THE ARTERIOTOMY. THE CARDIOLOGIST WHO IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE, LET THE THORACIC SURGEON ATTEMPT TO CLOSE THE ARTERY USING THE PROGLIDE DEVICE. AFTER THE SUTURE BROKE, A CUT-DOWN PROCEDURE WAS PERFORMED TO REMOVE THE SUTURE AND ACHIEVE HEMOSTASIS VIA SURGICAL CLOSURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE SURGICAL CUT-DOWN PROCEDURE AND SURGICAL CLOSURE. HEMOSTASIS WAS ACHIEVED IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRE-PLACED PROGLIDE SUTURE. REPORTEDLY THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185762 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 18F