BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904505 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02936
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 29, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.(B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND A POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET AND THE POSTERIOR NEEDLE WAS UNDISTURBED. THIS IS INDICATIVE OF POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM POSTERIOR FOOT POCKET INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR 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. ONE OF THE ANTERIOR CUFF TABS (304 STAINLESS STEEL, APPROX. 0.01 BY 0.01 INCHES) WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. DURING LAB TESTING THE PROXY 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 POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT 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 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 IN-TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, THERE WAS NO SUTURE PRESENT ON THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED. AFTER DEPLOYING THE SUTURE OF THE SECOND PROGLIDE DEVICE IN THE VESSEL, THE LONG WHITE SUTURE WAS "PULLED" RESULTING IN THE ENTIRE SUTURE BEING PULLED OUT FROM THE VESSEL. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND THE METHOD THAT HEMOSTASIS WAS ACHIEVED WAS NOT REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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 930026H

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention