BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2803316 · Received October 24, 2012

    Report

    Report Number
    2024168-2012-06712
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER,BECAUSE THE SUTURE, LINK, POSTERIOR CUFF AND POSTERIOR NEEDLE TIP WERE NOT RETURNED WITH THE DEVICE, THE SCOPE OF THIS INVESTIGATION WAS LIMITED AND THE REPORTED SUTURE BREAK COULD NOT BE CONFIRMED. THE ANALYSIS OF THE RETURNED DEVICE COMPONENTS REVEALED THAT THE LINK WAS PULLED FROM THE SWAGE END OF THE ANTERIOR CUFF DURING THE NEEDLE PLUNGER RETRACTION WHICH SUBSEQUENTLY RESULTED IN A FAILURE TO RETRIEVE THE SUTURE AND COULD APPEAR SIMILAR TO THE REPORTED SUTURE BREAK. BASED ON VISUAL AND FUNCTIONAL 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A SUTURE BREAK WAS NOTED. HEMOSTASIS WAS ACHIEVED USING A NON-ABBOTT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20622J1

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention