BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1901865 · Received November 17, 2010

    Report

    Report Number
    2953144-2010-02855
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE POSTERIOR CUFF WAS STILL LOADED ON THE FOOT AND THE LINK STILL ATTACHED TO THE CUFF. THERE WAS A NEEDLE STRIKE MARK ON THE POSTERIOR FOOT. THE ANTERIOR CUFF WAS ENGAGED TO THE ANTERIOR NEEDLE TIP AND THE LINK WAS BROKEN AT THE ANTERIOR CUFF. BASED ON THE EVIDENCE FOUND ON THE DEVICE, THE POSTERIOR CUFF WAS MISSED AND THE LINK BROKE AT THE ANTERIOR CUFF WHICH WAS A DIRECT RESULT OF THE POSTERIOR CUFF MISS. 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 BREAKING OF THE LINK FROM THE ANTERIOR CUFF. DURING THE INVESTIGATION, THE PLUNGER WAS REINSERTED AND THE NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE AS EVIDENCED BY THE NEEDLE STRIKE MARK ON THE FOOT. NO MANUFACTURING OR QUALITY ISSUES 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) THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.CONCOMITANT MEDICAL PRODUCTS (CONTINUED): HEPARIN. THE PERCLOSE PROGLIDE (PART# 12673-03, LOT# 920106H), IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.(B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    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 LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, 2 PROGLIDES FAILED, NO SUTURE WAS ATTACHED TO THE NEEDLES OF THE DEVICES. HEMOSTASIS WAS ACHIEVED USING A STARCLOSE SE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT. 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 920106H

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PERCLOSE PROGLIDE (PART# 12673-03, LOT#920106H).