BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904939 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02901
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SUTURE, LINK, POSTERIOR CUFF AND POSTERIOR NEEDLE WERE NOT RETURNED. EVALUATION OF THE RETURNED DEVICE FOUND THAT AN ANTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE ANTERIOR CUFF REMAINING IN THE FOOT POCKET AND THE ANTERIOR NEEDLE BEING UNDISTURBED. THIS IS INDICATIVE OF THE POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM ANTERIOR FOOT POCKET. BECAUSE THE ANTERIOR CUFF DID NOT CAPTURE THE NEEDLE DURING NEEDLE DEPLOYMENT, THE SUTURE COULD NOT BE RETRIEVED WHEN RETRACTING THE NEEDLE PLUNGER. SUBSEQUENTLY, BECAUSE THE LINK WAS HELD ON ONE END BY THE ANTERIOR CUFF REMAINING IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY PULLING THE SUTURE, THIS RESULTED IN A LINK BREAK AT THE ANTERIOR CUFF AS OBSERVED. DURING TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE ANTERIOR CUFF MISS AND SUBSEQUENT LINK DETACHMENT FROM THE ANTERIOR CUFF IS NEEDLE DEFLECTION DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.THE FIRST PERCLOSE PROGLIDE (PART 12673-03, LOT 920516H), INDICATED IS BEING FILED UNDER MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    A PATIENT'S CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 2 OF 6. THE CAREGIVER EXPLAINED THAT A SUPPLY BAG FELL AND DISCONNECTED. GTS HAD THE CAREGIVER CYCLE POWER AND ADVISED THEY WOULD NEED TO START OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED, A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED WITH ANOTHER PROGLIDE DEVICE. NO ADVERSE PATIENT EFFECT WAS REPORTED. ALTHOUGH 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 920516H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention