BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2220848 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05914
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. A CONCLUSIVE CAUSE FOR THE REPORTED SUTURE ENTANGLEMENT, WHICH LED TO THE FAILURE TO ACHIEVE HEMOSTASIS, COULD NOT BE DETERMINED. HOWEVER, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS DEVIATING FROM THE INSTRUCTIONS FOR USE (IFU) BY NOT REMOVING THE GUIDE WIRE PRIOR TO SUTURE DEPLOYMENT. SUTURE ENTANGLEMENT MAY OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO A MANUFACTURING DEFICIENCY, USER TECHNIQUE, OR PATIENT ANATOMICAL CONDITIONS. THE PATIENT REPORTEDLY HAD A HISTORY OF PRIOR ARTERIOTOMY CLOSURE IN THE TARGET GROIN AND PERIPHERAL VASCULAR DISEASE. THERE WAS NO REPORTED CALCIFIED PLAQUE OR TORTUOSITY AT THE ACCESS SITE. IN THIS CASE, IT WAS REPORTED THAT THE GUIDE WIRE WAS NOT REMOVED FROM THE PROGLIDE DEVICE SHEATH DURING SUTURE DEPLOYMENT, WHICH CAUSED THE SUTURE TO ENTANGLE. THE PROGLIDE DEVICE IFU UNDER DEVICE PLACEMENT, INSTRUCTS THE USER TO REMOVE THE GUIDE WIRE BEFORE THE EXIT PORT CROSSES THE SKIN LINE. THEREFORE, THE GUIDE WIRE SHOULD HAVE BEEN REMOVED WHEN SUTURES WERE DEPLOYED. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER INCIDENTS REPORTED FOR A SUTURE BREAK, WHICH WAS CAUSED BY USER ERROR. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. IN ADDITION, SAMPLINGS OF FINISHED DEVICES ARE DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE TO INCLUDE PROPER HARVESTING OF THE SUTURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE #2 PROGLIDE IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. (B)(4): FAILURE TO FOLLOW STEPS/INSTRUCTIONS. THE INSTRUCTIONS FOR USE INSTRUCT THE USER UNDER SMC DEVICE PLACEMENT TO BACKLOAD THE SMC DEVICE OVER THE GUIDE WIRE UNTIL THE GUIDE WIRE EXIT PORT OF THE SHEATH IS JUST BELOW THE SKIN LINE. REMOVE THE GUIDE WIRE BEFORE THE EXIT PORT CROSSES THE SKIN LINE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO ENDOVASCULAR ANEURYSM REPAIR PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES IN THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING TWO PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING SUTURE DEPLOYMENT, THE GUIDE WIRE WAS NOT REMOVED FROM THE PROGLIDE SHEATH, WHICH CAUSED SUTURE ENTANGLEMENT DURING REMOVAL. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT THE GUIDE WIRE WAS ALSO NOT REMOVED, WHICH CAUSED SUTURE ENTANGLEMENT. THE DEVICE WAS REMOVED AND TWO ADDITIONAL PROGLIDE DEVICES WERE USED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 060026H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PROCEDURAL SHEATH 6F