BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2873994 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07937
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS NOT CONFIRMED. THE ANALYSIS REVEALED THAT THE MONOFILAMENT WAS NOT RETURNED AND WITHOUT THE MONOFILAMENT THE REPORTED EVENT COULD NOT BE CONFIRMED OR VERIFIED. BASED ON THE VISUAL INSPECTION 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.

    Additional Manufacturer Narrative · 1

    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. IT WAS REPORTED THAT THE PROGLIDE DEVICE WAS USED IN A CALCIFIED VESSEL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE HEAVILY CALCIFIED RIGHT FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS WITHDRAWN, THE SUTURE WAS ALSO REMOVED FROM THE DEVICE. AN ATTEMPT WAS MADE TO RETRACT THE DEVICE FROM THE PATIENT ANATOMY AFTER THE LEVER WAS PUSHED DOWN, THE DEVICE WOULD NOT MOVE DUE TO RESISTANCE. THE LEVER WAS LIFTED AND PUSHED DOWN SEVERAL TIMES AND EVENTUALLY THE DEVICE WAS RETRIEVED FROM THE PATIENT ANATOMY. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT IS UNKNOWN IF THE PHYSICIAN IS 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 960316H

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention SHEATH: 6F PLAVIX, BAYASPIRIN, WARFARIN