BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1912598 · Received December 2, 2010

    Report

    Report Number
    2953144-2010-03062
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE SUTURE, LINK, POSTERIOR NEEDLE TIP, AND BOTH CUFFS WERE NOT RETURNED. WITHOUT THE RETURN OF THESE COMPONENTS, THE SCOPE OF THIS INVESTIGATION WAS LIMITED. INSPECTION INDICATED THAT THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT HAD OCCURRED DURING PLUNGER RETRACTION AS EVIDENCED BY DAMAGED ANTERIOR BARB. DURING TESTING, THE PLUNGER WAS REINSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE THAT COULD CONTRIBUTE TO THE CUFF-TO-NEEDLE TIP DETACHMENT. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT COULD NOT BE DETERMINED. 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). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. (B)(4). DEVICES #1 - PROGLIDE (PART #12673-03; LOT #930076H) ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WILL NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.

    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, AN UNSPECIFIED DEVICE FAILURE OCCURRED. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. THE METHOD OF HOW HEMOSTASIS WAS ACHIEVED WAS NOT REPORTED. 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-REDWOOD CITY 920376H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE #1: PROGLIDE (PART #12673-03, LOT #930076H)