BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1076398 · Received July 15, 2008

    Report

    Report Number
    2953144-2008-01169
    Event Type
    Injury
    Date Received
    July 15, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 23, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED; HOWEVER, UNUSED REP SAMPLES ARE BEING RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. DEVICE #2 - PROSTAR XL (PART#12322-01, LOT#63178-6H), IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FAILURE TO DEPLOY SUTURE (DEVICE #1). SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. TIME OF DEVICE MALFUNCTION AND SYMPTOMS/AE: DURING VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SUTURE "DID NOT FIRE RIGHT." A SECOND PROSTAR DEVICE WAS ATTEMPTED WITH THE SAME RESULTS. THE ARTERY WAS SUTURED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR REDWOOD CITY NA 63178-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention VESSEL CLOSURE: DEVICE #2 - PROSTAR XL| PART#12322-01