BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2001271 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01178
    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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE 1: PROSTAR (12322-02/940306H); GUIDE WIRE: 0.035 J-GIDE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE FIRST AND SECOND PROSTAR (12322-02/940306H), ARE EACH BEING FILED UNDER SEPARATE MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE DURING A PRECLOSE TECHNIQUE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE FIRST PROSTAR XL WAS INSERTED THROUGH THE GUIDE WIRE SUCCESSFULLY AND THE SUTURES WERE DEPLOYED. DURING DEVICE REMOVAL, TO MAINTAIN GUIDE WIRE ACCESS, AN ATTEMPT WAS MADE TO RE-INSERT THE NON-ABBOTT GUIDE WIRE, BUT DIFFICULTY WAS ENCOUNTERED AND IT COULD NOT BE ADVANCED PAST THE DISTAL END OF THE GUIDE WIRE EXIT PORT OF THE DEVICE. A SECOND NON-ABBOTT GUIDE WIRE WAS SUCCESSFULLY USED. THE FIRST DEVICE WAS REMOVED AND THE SECOND PROSTAR XL DEVICE WAS ATTEMPTED TO BE USED; HOWEVER, IT COULD NOT BE PLACED DUE TO THE CALCIFIED ARTERY. THE THIRD PROSTAR XL DEVICE ALSO COULD NOT BE PLACED DUE TO THE CALCIFICATION. AFTER THE INTERVENTIONAL PROCEDURE, THE SUTURES FROM THE FIRST PROSTAR XL TOGETHER WITH MANUAL COMPRESSION WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 940306H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention