BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1923767 · Received December 14, 2010

    Report

    Report Number
    2953144-2010-03215
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    May 25, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4) IMPROPER OR INCORRECT PROCEDURE OR METHOD (PATIENT SELECTION) THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE LINK MATERIAL WAS PULLED AND DETACHED FROM THE SWAGE END OF THE ANTERIOR CUFF. THE POSTERIOR CUFF REMAINED IN THE POSTERIOR FOOT POCKET WITH THE POSTERIOR CUFF TABS INTACT. NO NEEDLE STRIKE MARKS WERE DETECTED ON THE POSTERIOR PORTION OF THE FOOT, INDICATING THE NEEDLES WERE DEFLECTED OUTSIDE OF THE FOOT POCKET. THE NEEDLE PLUNGER, ANTERIOR NEEDLE, AND ANTERIOR CUFF WERE NOT RETURNED, WHICH LIMITED THE SCOPE OF THE EVALUATION. DURING TESTING, THE SUTURE WAS PULLED FROM THE DEVICE WITH NO SIGNIFICANT RESISTANCE DETECTED INDICATING THAT SUTURE DRAG WAS NOT A CONTRIBUTING FACTOR IN THIS EVENT. A PROXY NEEDLE PLUNGER WAS INSERTED RESULTING IN ACCEPTABLE NEEDLE TRAJECTORY. THE SUTURE WITH POSTERIOR NEEDLE REMAINED LOADED IN THE DEVICE AND THE POSTERIOR CUFF REMAINED IN THE POSTERIOR FOOT POCKET AFTER DEPLOYMENT INDICATING A POSTERIOR NEEDLE-TO-CUFF MISS OCCURRED. THIS RESULTED IN THE LINK DETACHING FROM THE SWAGE END OF THE ANTERIOR CUFF DUE TO RESISTANCE CREATED BY THE POSTERIOR CUFF. POSSIBLE CAUSES FOR A NEEDLE-TO-CUFF MISS ARE THE OPERATOR FAILS TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATION OF THE DEVICE AT ANY POINT DURING NEEDLE PLUNGER DEPLOYMENT, DEPLOYING THE DEVICE IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE NEEDLE PLUNGER, AND A FAILURE TO MAINTAIN AN ADEQUATE FOOT POSITION AGAINST THE ARTERIAL WALL. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE POSTERIOR NEEDLE-TO-CUFF MISS AND SUBSEQUENT FAILURE TO ACHIEVE HEMOSTASIS IS DUE TO NEEDLE DEFLECTION DURING NEEDLE PLUNGER DEPLOYMENT POSSIBLY CAUSED BY INTERACTION WITH ANATOMY OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    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 A HEAVILY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, THE SUTURE DETACHED FROM THE NEEDLE. THE DEVICE WAS REMOVED AND A SURGICAL SUTURE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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-REDWOOD CITY 870406H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention