BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2073370 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03060
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS RECEIVED. EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS OF THE RETURNED DEVICE FOUND THAT IT WAS PARTIALLY DEPLOYED. THE POSTERIOR FOOT HAD BEEN BROKEN OFF AND NOT RETURNED. THE COMPLETE SUTURE WITH POSTERIOR NEEDLE TIP WAS RETURNED PULLED OUT OF THE DEVICE. THE PLUNGER WITH THE ANTERIOR NEEDLE AND MOST LIKELY THE LINK AND CUFFS WERE NOT RETURNED. THESE FINDINGS ARE CONSISTENT WITH AND CONFIRMED THE REPORTED EXPERIENCE OF THE SUTURE NOT BEING PRESENT WHEN THE PLUNGER WAS REMOVED. BREAKAGE OF THE POSTERIOR FOOT DURING NEEDLE DEPLOYMENT PREVENTS CAPTURE OF THE POSTERIOR CUFF, WHICH IS INSIDE THE FOOT POCKET. BECAUSE THE SUTURE IS PULLED THROUGH THE DEVICE AFTER CUFF CAPTURE VIA THE ANTERIOR NEEDLE TIP TO CUFF ATTACHMENT, THE SUTURE COULD NOT BE HARVESTED. DUE TO THE BROKEN POSTERIOR FOOT, THE NEEDLE TRAJECTORY TEST COULD NOT BE PERFORMED. A FOOT BREAK CAN BE CAUSED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO MANUFACTURING OR DEPLOYMENT IN A CHALLENGING ANATOMY CAUSING THE NEEDLE/S TO DEFLECT AND STRIKE THE FOOT, AND BREAKING IT. CALCIFICATION OR OTHER BODY MATERIAL TRAPPED UNDER THE FOOT DURING DEPLOYMENT CAN INTERFERE AND MAY BREAK THE FOOT. ALSO, INABILITY TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING DEPLOYMENT CAN PUT PRESSURE ON THE FOOT CAUSING IT TO BREAK. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. BASED ON THE ANALYSIS, THE REPORTED INABILITY TO HARVEST THE SUTURE AND FOOT BREAK EXPERIENCED DURING THE PROCEDURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATES THAT AFTER REMOVAL OF THE PLUNGER, A CUFF MISS WAS THOUGHT TO HAVE OCCURRED AS THE ANTERIOR NEEDLE WAS NOT CAPTURED BY THE ANTERIOR CUFF. THE DEVICE WAS THEN REMOVED FROM THE ANATOMY. TWO WEEKS POST PROCEDURE, THE PATIENT WAS EXAMINED AT THE HOSPITAL AND IT WAS CONFIRMED THAT THE PAIN WAS GONE. THERE WAS NO TREATMENT FOR THE PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PERCLOSE PROGLIDE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE MODERATELY TORTUOUS AND NOT CALCIFIED RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE DEVICE WAS REMOVED FROM THE ANATOMY, THE SUTURES WERE NOT ABLE TO CLOSE THE ARTERY. ANOTHER PROGLIDE WAS ATTEMPTED, AND IT WAS INDICATED THAT THERE WAS NO RESISTANCE AND IT WAS ABLE TO BE INSERTED INTO THE VESSEL SMOOTHLY, AND ACHIEVED HEMOSTASIS. THE FOLLOWING DAY THE PATIENT COMPLAINED OF A LITTLE PAIN AT THE ACCESS SITE; THERE WAS NO REPORTED TREATMENT FOR THE PAIN. NO ADVERSE PATIENT SEQUELA WAS REPORTED. THE PHYSICIAN INDICATED HE WOULD LIKE TO KNOW IF THE DEVICE FEET WERE BROKEN. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. ONLY ONE DEVICE WAS RETURNED. ANALYSIS OF THAT DEVICE FOUND THE POSTERIOR FOOT WAS DETACHED AND WAS NOT RETURNED.

    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 920166H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention HEPARIN