BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2000628 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01136
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH A KNOT FORMED AND SUTURE BIGHT STILL LOADED ON THE SUTURE BEARING. BASED ON THIS CONDITION, THE CUFFS WERE SUCCESSFULLY CAPTURED WHICH MEANS THE DEVICE DOES NOT MATCH THE COMPLAINT; HOWEVER, A PLUNGER WAS ALSO RETURNED WITH THE ANTERIOR CUFF ENGAGED TO THE ANTERIOR NEEDLE TIP. BOTH CUFFS WERE ATTACHED TO THE LINK AND THE POSTERIOR CUFF TABS WERE BENT AND UNDISTURBED. BASED ON THESE FINDINGS, IT APPEARED THAT THE RETURNED COMPONENT BELONG TO 2 DIFFERENT DEVICES. SINCE THE REPORTED COMPLAINT IS ABOUT SUTURE RETRIEVAL, THE BASIS OF THIS INVESTIGATION WILL BE ON THE PLUNGER. BASED ON THE OBSERVATION OF THE RETURNED PLUNGER, THE POSTERIOR CUFF WAS MISSED AND THIS CONFIRMED THE REPORTED COMPLAINT. THE POSTERIOR CUFF TABS WERE BENT PROPERLY AND UNDISTURBED. DURING THE INVESTIGATION, THE PLUNGER WAS LOADED IN A PROXY DEVICE AND THE PUSH MANDREL TRAVEL WAS CHECKED AND IT WAS ACCEPTABLE. ALSO, THE NEEDLE TRAJECTORY IS CHECKED TWICE DURING THE MANUFACTURE OF THE DEVICE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE DURING NEEDLE DEPLOYMENT. 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.

    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. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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-TEMECULA-CT 950076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention