BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 6210383 · Received December 28, 2016

    Report

    Report Number
    2024168-2016-09292
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    December 2, 2016
    Report Date
    February 2, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE DIFFICULTY INSERTING THE GUIDE WIRE WAS NOT CONFIRMED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE DIFFICULTY INSERTING THE GUIDE WIRE; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WITH A PROGLIDE DEVICE WAS ATTEMPTED IN THE LEFT COMMON FEMORAL ARTERY (LCFA) USING THE PRECLOSE TECHNIQUE PRIOR TO AN INTERVENTIONAL PROCEDURE TO INSERT AN IMPELLA DEVICE IN THE HEART. THE ARTERIOTOMY WAS 8FR. REPORTEDLY, THE PROGLIDE DEVICE COULD NOT BE ADVANCED OVER THE 0.035 GUIDE WIRE. TWO ADDITIONAL PROGLIDE DEVICES WERE USED FOR SUCCESSFUL SUTURE PLACEMENT USING THE PRECLOSE TECHNIQUE. THE SHEATH WAS UPSIZED TO 12FR AND THE IMPELLA PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED USING THE PRE-PLACED SUTURES FROM PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858454 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 6082341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8FRHEPARIN