BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2802173 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06706
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY INSERTING A GUIDE WIRE INTO THE GUIDE WIRE EXIT PORT OF THE DEVICE WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT-HANDLING DATABASE INDICATED THERE ARE NO SIMILAR INCIDENTS REPORTED FROM THIS LOT FOR THIS DEFICIENCY. BASED ON AN EXPANDED INVESTIGATION, THERE IS A POSSIBLE PRODUCT ISSUE RELATED TO THE DIFFICULT TO INSERT GUIDE WIRE THROUGH THE GUIDE WIRE EXIT PORT. FURTHER ASSESSMENT OF THIS ISSUE WAS CONDUCTED PER SITE OPERATING PROCEDURES. CORRECTIVE AND PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE HAVE BEEN CONDUCTED AND THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL SUTURE DEPLOYMENT IN THE RIGHT COMMON FEMORAL ARTERY, DIFFICULTY WAS EXPERIENCED RELOADING THE GUIDE WIRE THROUGH THE PROGLIDE GUIDE WIRE EXIT PORT. AFTER A CORONARY INTERVENTIONAL PROCEDURE THE PHYSICIAN DEPLOYED THE PROGLIDE SUTURES UNEVENTFULLY; HOWEVER, HE WANTED TO MAINTAIN WIRE ACCESS AND ATTEMPTED TO RE-INSERT A 0.035 J STRAIGHT TIP GUIDE WIRE THROUGH THE GUIDE WIRE PORT, BEFORE KNOT ADVANCEMENT. THE GUIDE WIRE WOULD NOT ADVANCE AND THE PHYSICIAN ATTEMPTED RE-INSERTING THE GUIDE WIRE USING THE BACK END OF THE SAME GUIDE WIRE. DIFFICULTY WAS ALSO EXPERIENCED RELOADING THE GUIDE WIRE, BUT IT WAS ULTIMATELY RE-INSERTED INTO THE GUIDE WIRE EXIT PORT. THE CLOSURE PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED WITH THE PROGLIDE SUTURES. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 20721J1

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SHEATH: 6 FR