BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2854107 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07624
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PATIENT REPORTED TO BE AVERAGE BUILD. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. 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 OF SUTURE NOT PRESENT DURING PLUNGER RETRACTION WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, DURING THE INVESTIGATION IT WAS FOUND THAT AN ANTERIOR CUFF TAB WAS BROKEN OFF AND NOT RETURNED. 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 ATTEMPTED USING A PROGLIDE DEVICE IN A COMMON FEMORAL ARTERY PRIOR TO A CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, THERE WAS NO SUTURE PRESENT WHEN THE PLUNGER WAS RETRACTED FROM THE DEVICE BODY. THE ARTERIOTOMY WAS 6 FR AND THE SHEATH WAS UPSIZED TO 12 FR TO PERFORM THE INDEX PROCEDURE. AFTER COMPLETION OF THE PROCEDURE IT WAS INDICATED THAT HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION WITH NO ADVERSE EFFECT TO THE PATIENT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 20821J1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SHEATH: 6 FR, 12 FRHEPARIN