BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2862629 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07760
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). LOT NUMBER - CORRECTION - CHANGED FROM 20117J1 TO 20120J1. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF UNSUCCESSFUL ARTERIAL BLOOD MARKING WAS NOT CONFIRMED, BECAUSE KEY COMPONENTS (PLUNGER, SUTURE, LINK, NEEDLES AND CUFFS) WERE NOT RETURNED. 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. 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 AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, NO PULSATE BLOOD FLOW WAS CONFIRMED TO BE COMING OUT OF THE MARKER TUBE, THUS NO FURTHER MANIPULATION WAS PERFORMED AND THE DEVICE WAS PULLED OUT OF THE ANATOMY. HEMOSTASIS WAS ACHIEVED BY MANUAL ARTERIAL COMPRESSION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. IT WAS INDICATED THAT THE DEVICE WAS NOT FLUSHED PRIOR TO USE. HOWEVER, IT WAS FLUSHED AFTER REMOVAL FROM THE PATIENT AND FLUID WAS SEEN COMING OUT FROM THE MARKER PORT. SLIGHT AMOUNT OF THROMBOSIS WAS OBSERVED AROUND THE MARKER PORT, BUT NO NOTICEABLE FOREIGN MATERIAL. 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 20120J1

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SHEATH: 7 FR