BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2233567 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06139
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 8, 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 NOTED THAT THE DEVICE WAS PARTIALLY DEPLOYED. THE SUTURE WAS RETURNED COMPLETE AND INTACT. THIS FINDING IS NOT CONSISTENT WITH THE REPORT OF SUTURE BROKE WHEN THE DEVICE WAS BEING WITHDRAWN FROM THE PATIENT AND THE TWO SUTURE ENDS WERE BEING REMOVED FROM THE DEVICE. THE ANALYSIS NOTED THAT A POSTERIOR CUFF MISS HAD OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF BEING RETURNED LOOSE WITH THE CUFF TABS IN THE PREDEPLOYED CONDITION AND NO NEEDLE STRIKE MARKS AT THE POSTERIOR FOOT. A NEEDLE TO CUFF MISS HAS THE SAME APPEARANCE AND COULD RESULT IN PREVENTING THE SUTURE RETRIEVAL FROM ACHIEVING HEMOSTASIS WITH THIS DEVICE. THE NEEDLE TIP MISSING THE CUFF DURING DEPLOYMENT PREVENTS RETRIEVAL OF THE SUTURE DURING DEPLOYMENT. DURING TESTING, THE PLUNGER WAS INSERTED INTO THE DEVICE TO TEST THE NEEDLE TRAJECTORY, DEPTH AND MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE TEST RESULTS INDICATE THAT NEEDLE TRAJECTORY WAS NOT A CONTRIBUTING FACTOR IN THE EVENT. NO PRODUCT QUALITY DEFICIENCY WAS NOTED. A CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, 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. THE PROBABLE CAUSE FOR THE NOTED NEEDLE TO CUFF MISS APPEARS TO BE RELATED TO THE OPERATIONAL INFLUENCES DURING USE AND NOT A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED TWICE DURING MANUFACTURING. TO HELP ENSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    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 ATTEMPTED ARTERIOTOMY CLOSURE OF A NON-CALCIFIED COMMON FEMORAL ARTERY (CFA) AFTER A CHEMO EMBOLIZATION PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, THE SUTURE BROKE WHEN THE DEVICE WAS BEING WITHDRAWN FROM THE PATIENT AND THE TWO SUTURE ENDS WERE BEING REMOVED FROM THE DEVICE. A SECOND PROGLIDE WAS THEN ATTEMPTED AND WAS SUCCESSFUL ACHIEVING HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THE ACCESS SITE WAS DESCRIBED AS CLEAN. A 6 FR. SHEATH WAS USED DURING THE CLOSURE PROCEDURE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 050366H

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SHEATH: 6 FR.