BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2073303 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03041
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED PARTIALLY DEPLOYED. THE COMPLETE SUTURE WITH THE POSTERIOR NEEDLE TIP WAS LOADED IN THE DEVICE. THE POSTERIOR CUFF WITH THE LINK WAS STILL IN THE FOOT POCKET AND THE CUFF TABS WERE UNDISTURBED. THE ANTERIOR CUFF HAD DETACHED FROM THE NEEDLE TIP. BASED ON THE INVESTIGATION FINDINGS, A POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. BECAUSE THE NEEDLE DID NOT ENGAGE THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE. THE POSTERIOR CUFF MISS RESULTING IN AN ANTERIOR CUFF TO NEEDLE TIP DETACHMENT WOULD PREVENT THE SUTURE FROM BEING HARVESTED FROM THE DEVICE. BASED ON THESE FINDINGS, THE REPORTED NEEDLE TO CUFF MISS EXPERIENCE IS CONFIRMED. THE DISTAL END OF THE GUIDE TUBE WAS FOUND BENT AND IT COULD NOT BE DETERMINED IF THIS DAMAGE OCCURRED DURING OR POST THE PROCEDURE. THE POSTERIOR FOOT WAS EXAMINED AND NO NEEDLE STRIKE MARKS WERE DETECTED INDICATING THE POSTERIOR NEEDLE WAS DEFLECTED OUTSIDE OF THE FOOT POCKET DURING DEPLOYMENT. 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, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND / OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. BASED ON THE INVESTIGATION, THE EXPERIENCED CUFF MISS DURING THE PROCEDURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING DEPLOYMENT, THE SUTURES WERE NOT RETRIEVED. THE DEVICE WAS REMOVED AND A STARCLOSE SE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 010166H

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention