BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1051055 · Received May 22, 2008

    Report

    Report Number
    2953144-2008-00937
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. DEVICE #1 PROSTAR XL, LOT # 62112-6H, INDICATED IS BEING FILED UNDER MEDWATCH MANUFACTURER REPORT NUMBER: 2953144-2008-00936.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: RESISTANCE DURING NEEDLE REMOVAL, SUTURE DIDN'T PRESENT. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN USED THE PROSTAR XL DEVICE TO ATTEMPT ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AS THE NEEDLES WERE BEING REMOVED, RESISTANCE WAS ENCOUNTERED AND THE SUTURES WERE NOT ATTACHED TO THE NEEDLES. THE ENDS OF THE SUTURES COULD NOT BE FOUND AND THE SUTURE LOOP WAS STILL ATTACHED TO THE BARREL. THE CLOSURE DEVICE WAS REMOVED AND A SECOND PROSTAR XL WAS ATTEMPTED WITH THE SAME RESULTS. THE DEVICE WAS REMOVED AND DUE TO THE SIZE OF THE ACCESS SITE, TWO PROGLIDES WERE 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 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR REDWOOD CITY NA 62112-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #1 PROSTAR XL