BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904638 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02872
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 11, 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). 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

    (B)(4). EVALUATION SUMMARY: THE WHOLE SUTURE WAS RETURNED UNDAMAGED AND PARTIALLY EXPOSED. THE PLUNGER, THE ANTERIOR NEEDLE AND ANTERIOR CUFF WERE NOT RETURNED. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THE POSTERIOR NEEDLE TIP WAS BENT AND THERE WAS A NEEDLE STRIKE MARK AT THE POSTERIOR FOOT. THIS IS INDICATIVE OF POSTERIOR NEEDLE STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH 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, RESULTING IN THE DETACHING FROM THE ANTERIOR CUFF. DURING LAB TESTING, A 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 LINK BREAK AT 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 ISSUE WAS DETECTED. 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 PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE BUTTONS ON HIS INFUSION DEVICE ARE FUNCTIONING INTERMITTENTLY. PT STATED HE STARTED NOTICING THE ISSUE A COUPLE OF WEEKS AGO. PT REPORTED THE UP AND DOWN BUTTONS ARE NOT ALWAYS RESPONDING FOR HIM. PT STATED HE NOTICED THIS ISSUE WHILE ATTEMPTING TO BOLUS. PT IS NOT ABLE TO SEE THE SCREEN VERY WELL DUE TO VISION CONCERNS. PT REPORTED THE BUTTONS POP BACK UP AFTER BEING PRESSED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    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 Required Intervention