BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1924091 · Received December 14, 2010

    Report

    Report Number
    2953144-2010-03226
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 19, 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. 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 REVEALED THE NEEDLE PLUNGER, THE COMPLETE SUTURE, POSTERIOR NEEDLE, LINK MATERIAL, ANTERIOR CUFF, AND POSTERIOR CUFF, WHICH LIMITED THE SCOPE OF THE INVESTIGATION. THERE WAS NO DETECTED DAMAGE TO THE DEVICE HANDLE, GUIDE TUBE, GUIDE, FOOT, OR SHEATH. BLOW THROUGH MARKS WERE PRESENT ON THE POSTERIOR FOOT INDICATING THE POSTERIOR CUFF HAD BEEN EJECTED FROM THE POSTERIOR FOOT. INSPECTION OF THE FOOT ASSEMBLY DID NOT DETECT ANY DAMAGE INDICATING A POSSIBLE NEEDLE-TO-CUFF MISS, NEEDLE STRIKE, OR POSSIBLE MALFUNCTION OF THE DEVICE. DURING LAB TESTING, A PROXY NEEDLE PLUNGER WAS INSERTED RESULTING IN PROPER NEEDLE TRAJECTORY WITH THE ANTERIOR AND POSTERIOR NEEDLES ENTERING THEIR RESPECTIVE FOOT POCKETS. ADDITIONALLY, EVERY DEVICE IS CHECKED TWICE FOR PROPER NEEDLE TRAJECTORY DURING MANUFACTURING. THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. BASED ON THE INVESTIGATION, THE PROBABLE ROOT CAUSE FOR THE NEEDLE-TO-CUFF MISS IS NEEDLE DEFLECTION DURING NEEDLE PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE NEEDLE PLUNGER, AND A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. 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 THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, THERE WAS NO SUTURE ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE 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 930106H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention