BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3051481 · Received April 10, 2013

    Report

    Report Number
    2024168-2013-02190
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE CUSTOMER RETURNED THREE UNUSED STERILE PROGLIDE DEVICES FOR EVALUATION. ALTHOUGH THE DEVICES HAVE THE SAME PART NUMBER (12673-05) AS THE COMPLAINT DEVICE, THE DEVICES ARE FROM A DIFFERENT LOT (21213J1). THE DEVICES PASSED FUNCTIONAL TESTING WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED DEVICES. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. BASED ON THE VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICES, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. REPORTEDLY, MILD POSTERIOR CALCIFICATION WAS OBSERVED OF THE RIGHT COMMON FEMORAL ARTERY. THE DEVICE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS ENDOVASCULAR ANEURYSM REPAIR (PEVAR) PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN A RIGHT COMMON FEMORAL ARTERY WITH MILD POSTERIOR CALCIFICATION THROUGH A 7-FRENCH SIZED ACCESS SITE USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING DEPLOYMENT OF TWO PROGLIDE DEVICES, EACH DEVICE WAS HELD AT AN ANGLE OF 45-DEGREES TO THE LONGITUDINAL PLANE OF THE ARTERY, BUT THE SUTURE WOULD NOT COME OUT OF THE DEVICES AND HAD TO BE CUT. TWO ADDITIONAL DEVICES WERE SEQUENTIALLY DEPLOYED APPROXIMATELY 60-DEGREES OPPOSITE IN ORIENTATION AND SET TO THE SIDE. THE ACCESS SITE WAS DILATED TO 18-FRENCH. AFTER CONCLUSION OF THE PEVAR PROCEDURE, THE KNOTS FROM THE TWO ADDITIONAL PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE REPORTED ISSUE DELAYED THE PEVAR PROCEDURE BY APPROXIMATELY TEN MINUTES. ALTHOUGH THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, THE LEVEL OF ANESTHESIA WAS NOT CHANGED DUE A COMPLICATION WITH THE PROGLIDE DEVICES. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153806 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21113J1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention SHEATHS: 7-FRENCH, 18-FRENCH, HEPARIN 5000 UNITS