BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3143254 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03459
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 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
    IA, 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. IT WAS REPORTED THAT THE RIGHT COMMON FEMORAL ARTERY WAS MODERATELY CALCIFIED. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. BASED ON THE REPORTED INFORMATION AND THE INSPECTION CRITERIA A CAUSE FOR THE REPORTED EVENT AND ASSOCIATED PATIENT EFFECTS WAS RELATED TO THE OPERATIONAL CONTEXT OF USING THE DEVICE IN A MODERATELY CALCIFIED COMMON FEMORAL ARTERY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 THE PROGLIDE DEVICE IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN IMPELLA INTERVENTIONAL PROCEDURE. THE ARTERIOTOMY WAS A 6F AND MODERATELY CALCIFIED. DURING THE IMPELLA PROCEDURE THE SHEATH WAS UPSIZED TO A 14F. REPORTEDLY, AFTER THE INTERVENTIONAL PROCEDURE THE SUTURES OF THE SECOND PROGLIDE BROKE. A THIRD PROGLIDE DEVICE WAS USED AND HEMOSTASIS WAS ACHIEVED USING THE SUTURES OF THE PRE-PLACED FIRST PROGLIDE AND THE DEPLOYED THIRD PROGLIDE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE FOR PRECLOSE PROCEDURES. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244354 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30321K1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SHEATH: 6FR, 14FR