BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1934938 · Received December 21, 2010

    Report

    Report Number
    2953144-2010-03324
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER, LINK, ANTERIOR NEEDLE, AND BOTH CUFFS WERE NOT RETURNED, WHICH LIMITED THE SCOPE OF THIS INVESTIGATION. INSPECTION OF THE DEVICE REVEALED A DAMAGED POSTERIOR NEEDLE BARB, CONSISTENT WITH BEING DETACHED FROM THE POSTERIOR CUFF DURING THE NEEDLE PLUNGER RETRACTION. CUFF TO NEEDLE TIP DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE WHEN RETRACTING THE PLUNGER AND THIS COULD APPEAR VERY SIMILAR TO THE REPORTED MISFIRE DURING USE; THEREFORE, THE REPORTED EXPERIENCE IS CONFIRMED. DURING TESTING, THE PROXY PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY RESISTANCE THAT COULD CONTRIBUTE TO A CUFF TO NEEDLE TIP DETACHMENT. THE WHOLE SUTURE WAS ABLE TO BE PULLED OUT FROM THE DEVICE WITHOUT ANY OBSERVABLE RESISTANCE TO SUGGEST A POSSIBLE SUTURE DRAG MIGHT HAVE OCCURRED, WHICH COULD RESULT IN THE POSTERIOR CUFF DETACHING FROM THE NEEDLE TIP DURING PLUNGER RETRACTION. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE POSTERIOR CUFF TO NEEDLE TIP DETACHMENT COULD NOT BE DETERMINED. 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WHO IS TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE MISFIRED AND HEMOSTASIS WAS ACHIEVED USING A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA 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-REDWOOD CITY 940046H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention