BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2251449 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06360
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    October 27, 2010
    Report Date
    August 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 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. THE ADDITIONAL PROGLIDES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE COMPONENTS, BODY OF THE DEVICE, HANDLE TO FOOT FUNCTION, GUIDE TUBE, NEEDLE GUIDE, BRIDGE, SUTURE BEARING, EXIT RAMP AND SHEATH WERE NORMAL WITH, THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY THAT WOULD CONTRIBUTE TO THE REPORTED CUFF MISS. THE ANTERIOR CUFF WAS STILL LOADED INSIDE THE FOOT POCKET. BASED ON THE EVIDENCE FOUND ON THE RETURNED DEVICE, THE ANTERIOR CUFF WAS MISSED AND THIS CONFIRMED THE REPORTED COMPLAINT. THERE WAS NO NEEDLE STRIKE MARK ON THE FOOT. DURING THE INVESTIGATION, A PROXY PLUNGER WAS INSERTED AND THE NEEDLE TRAJECTORY WAS ACCEPTABLE AND THE ANTERIOR CUFF WAS CAPTURED SUCCESSFULLY. CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT RESULTED IN THE ANTERIOR CUFF MISS INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. BASED ON THE SUCCESSFUL TEST OF THE DEVICE NEEDLE TRAJECTORY IN THE LAB AND DURING MANUFACTURING, THE PROBABLE CAUSE FOR THE ANTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREES ANGLE THROUGHOUT DEPLOYMENT. IT WAS REPORTED THAT THE COMMON FEMORAL ARTERY WAS MODERATELY CALCIFIED AND THIS COULD BE A CONTRIBUTING FACTOR FOR THE CUFF MISS. THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (IFU) STATE UNDER SPECIAL PATIENT POPULATIONS, THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED, IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE AN INDICATION OF A PRODUCT QUALITY PROBLEM.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED. A PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE PLASTIC PART WAS PULLED, THE PROLENE SUTURE WAS NOT ATTACHED TO THE METAL SHAFT, CLOSURE COULD NOT BE COMPLETED. THE SAME RESULTS OCCURRED WITH ALL THREE UNITS. AN UNKNOWN CLOSURE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. 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 860156H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN