BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3063686 · Received April 17, 2013

    Report

    Report Number
    2024168-2013-02359
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ATTEMPTED SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE, THERE WAS DIFFICULTY INSERTING THE DEVICE. THE DEVICE WAS REMOVED WITH THE FOOT OPEN. REPORTEDLY, AFTER DEVICE REMOVAL IT WAS OBSERVED THAT THE DISTAL GUIDE WAS KINKED. THE ARTERIOTOMY WAS 6F. THE AAA PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED BY SURGICAL CUT-DOWN AND ARTERY REPAIR. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166234 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21127J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 20F HEPARIN