BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1951313 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00067
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED WITHOUT THE PLUNGER AND NEEDLES, THE COMPLETE SUTURE, POSTERIOR NEEDLE TIP, ANTERIOR AND POSTERIOR CUFFS, AND LINK MATERIAL, 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 TO INDICATE A POSSIBLE CUFF MISS, NEEDLE STRIKE, OR POSSIBLE MALFUNCTION OF THE DEVICE. DURING TESTING, A PROXY PLUNGER/NEEDLE ASSEMBLY WAS USED TO TEST FOR NEEDLE TRAJECTORY AND THE RESULT WAS ACCEPTABLE. EVERY DEVICE IS CHECKED TWICE FOR PROPER NEEDLE TRAJECTORY DURING MANUFACTURING. A POSSIBLE CAUSE FOR THE REPORTED CUFF MISS MAY HAVE BEEN NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE PLUNGER, OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT; HOWEVER, NONE OF THE POSSIBLE CAUSES OR THE CUFF MISS COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THERE WAS NO DETECTED MANUFACTURING OR QUALITY ISSUE. THE DEVICE PERFORMED ACCORDING TO SPECIFICATION AND THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. ANOTHER PROGLIDE DEVICE WAS USE TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED. 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 910266H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention