BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1905020 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02916
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 6, 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
    TX, 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: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE ANTERIOR CUFF AND LINK WERE ENGAGED TO THE ANTERIOR NEEDLE TIP. THE POSTERIOR CUFF, NEEDLE TIP AND MONOFILAMENT WERE NOT RETURNED WITH THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, THE LINK WAS PULLED FROM THE POSTERIOR CUFF. THE LINK CONNECTS THE ANTERIOR NEEDLE TO THE SUTURE AND IF THE LINK DETACHES FROM THE CUFF, THE SUTURE WILL NOT BE PRESENT DURING PLUNGER WITHDRAWAL AND MAY APPEARED LIKE A CUFF MISSED. THE LINK DETACHMENT IS LIKELY THE RESULT OF RESISTANCE OR DRAG ENCOUNTERED DURING THE PROCEDURE. 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 PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A CUFF MISS OCCURRED. THE PROGLIDE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A NON-ABBOTT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    WHILE TRYING TO SET UP THE ENDOPLEGE SINUS CATHETER KIT AT THE BEGINNING OF THE CASE, WE WERE UNABLE TO ENGAGE THE SHEATH TO THE CATHETER TO TIGHTEN OR CONNECT IT. THE THREADED END ACTED LIKE IT WAS GOING ON BUT WOULD NOT TIGHTEN AND THE CATHETER WAS FREE TO MOVE BACK AND FORTH. WE HAD TO OPEN UP ANOTHER KIT TO USE.

    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 930076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention