BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3970151 · Received July 31, 2014

    Report

    Report Number
    2024168-2014-04879
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS. USED TO ADDRESS THAT THE GUIDE WIRE WAS NOT REMOVED PRIOR TO SUTURE DEPLOYMENT. THE INSTRUCTIONS FOR USE STATES: BACKLOAD THE DEVICE OVER THE GUIDE WIRE UNTIL THE GUIDE WIRE EXIT PORT OF THE DEVICE SHEATH IS JUST ABOVE THE SKIN LINE. REMOVE THE GUIDE WIRE BEFORE THE EXIT PORT CROSSES THE SKIN LINE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT WAS REPORTED THAT THE GUIDE WIRE WAS NOT REMOVED FROM THE PATIENT AND THE SUTURES GOT TRAPPED WITH THE GUIDE WIRE. THE INSTRUCTIONS FOR USE, STATES: BACKLOAD THE DEVICE OVER THE GUIDE WIRE UNTIL THE GUIDE WIRE EXIT PORT OF THE DEVICE SHEATH IS JUST ABOVE THE SKIN LINE. REMOVE THE GUIDE WIRE BEFORE THE EXIT PORT CROSSES THE SKIN LINE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A CAROTID STENTING PROCEDURE, THE SUTURE OF A PROGLIDE DEVICE WAS ATTEMPTED TO BE PLACED IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS 9F. REPORTEDLY, THE CLOSURE PROCEDURE HAD TO BE ABORTED BECAUSE THE GUIDE WIRE WAS NOT REMOVED FROM THE PATIENT AND THE SUTURES GOT TRAPPED WITH THE GUIDE WIRE. THE GUIDE WIRE AND SUTURE WERE DIFFICULT TO REMOVE AND CAUSED SOME VESSEL DAMAGE. AFTER THE CAROTID STENTING PROCEDURE, THE VESSEL WAS REPAIRED AND HEMOSTASIS WAS ACHIEVED WITH SURGICAL INTERVENTION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446580 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 9F, HEPARIN