BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2073282 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03036
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS EVENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PHYSICIANS, IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED BILATERAL ARTERIOTOMY CLOSURE OF THE RIGHT AND LEFT COMMON FEMORAL ARTERIES AFTER AN ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) PROCEDURE. THE PHYSICIANS HAD INTENDED TO PUT 2 PROGLIDE SUTURES INTO EACH FEMORAL ARTERY. REPORTEDLY, AT THE BEGINNING OF THE PROCEDURE, USING A PRE-CLOSURE TECHNIQUE, TWO PROGLIDES WERE ATTEMPTED IN THE LEFT GROIN. DURING REMOVAL OF THE SECOND DEPLOYED PROGLIDE, THE SUTURE LOOP WAS ABLE TO BE PULLED OUT INTACT. A THIRD PROGLIDE WAS ATTEMPTED, DEPLOYMENT COMPLETED, HOWEVER AT THE END OF THE PROCEDURE, THE PHYSICIAN WAS NOT HAPPY WITH THE CLOSURE; THE GROIN SITE WENT TO CUT DOWN TO ACHIEVE HEMOSTASIS. ADDITIONALLY, DURING ATTEMPTED PRE-CLOSURE OF THE RIGHT GROIN, 7 PROGLIDE DEVICES WERE ATTEMPTED; ONE WAS SUCCESSFULLY DEPLOYED AND 6 OF THEM FAILED, THE SUTURE LOOP WAS ABLE TO BE PULLED OUT INTACT IN ALL OF THEM. AT THE END OF THE PROCEDURE, THE RIGHT GROIN WENT TO CUT DOWN AND HEMOSTASIS WAS ACHIEVED SURGICALLY. AN ABBOTT REPRESENTATIVE WAS AT A SHORT DISTANCE DURING THE PROCEDURE AND INDICATES THE PHYSICIANS OPERATED THE DEVICE ACCORDING TO THE CORRECT TECHNIQUE. THE REPORT RECEIVED INDICATES THE PROCEDURE WAS DELAYED APPROXIMATELY 30 MINUTES DUE TO THE DEVICE ISSUES EXPERIENCED. NO ADVERSE PATIENT SEQUELA OCCURRED. THOUGH REQUESTED, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention TWO 6FR SHEATHS. HEPARIN.