BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131474 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04257
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS DEPLOYED WITH BLOOD PRESENT IN THE DEVICE. THE SUTURE WAS RETURNED CUT INTO TWO PIECES, TOTALING 18 3/4 INCHES LENGTH. THE LINK, CUFFS, POSTERIOR NEEDLE TIP AND APPROXIMATELY 1 1/4 INCH OF THE SUTURES WAS NOT RETURNED FOR INVESTIGATION. BOTH ENDS OF THE FOOT WERE EXAMINED AND THERE WERE NO NEEDLE STRIKE MARKS DETECTED. DURING TESTING A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND THE RESULTS WERE ACCEPTABLE. THE DEVICE NEEDLE TRAJECTORY IS INSPECTED DURING MANUFACTURING TO ASSURE IT IS WITHIN SPECIFICATION. THE SUTURE WAS RETURNED CUT INTO TWO PIECES WITHOUT THE CUFF, POSTERIOR NEEDLE TIP OR THE ANTERIOR CUFF ATTACHED TO THE NEEDLE TIP AND IS NOT CONSISTENT WITH A NORMALLY DEPLOY CONDITION. THESE FINDINGS DO NOT INDICATE A SPECIFIC FAILURE MODE, BUT INDICATE THAT SEVERAL EVENTS MAY HAVE OCCURRED. THE CUT SUTURE INDICATES THAT THE REPORTED EXPERIENCE MAY HAVE OCCURRED AFTER THE SUTURE WAS DEPLOYED IN THE ATERIOTOMY, THE SUTURE NEEDED TO BE CUT TO BE REMOVED. DURING NEEDLE DEPLOYMENT A POSTERIOR CUFF MISS MAY HAVE OCCURRED RESULTING IN A ANTERIOR CUFF DETACHMENT, THIS IS CONSISTENT WITH THE PLUNGER AND ANTERIOR NEEDLE TIP BEING RETURNED WITHOUT THE CUFF ATTACHED. BOTH POSSIBLE EVENTS COULD NOT OCCUR TOGETHER. ANOTHER POSSIBILITY IN THIS CASE IS THAT A DIFFERENT DEVICE OR COMPONENTS WERE RETURNED FOR THIS CASE. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING AND OR A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. IT WAS REPORTED IN THIS CASE THAT THE ACCESS SITE WAS SCARRED; A CUFF-MISS CAN BE INFLUENCED BY DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND / OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. BASED ON THE INVESTIGATION FINDINGS, THE CAUSE FOR THE REPORTED EVENT CLOUD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS EVENT.

    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. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A SCARRED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AN UNKNOWN DEVICE FAILURE OCCURRED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 030126H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention