BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1851794 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02337
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FULLY DEPLOYED. ALL OF THE DEVICE COMPONENTS WERE UNDAMAGED AND IN THE NORMAL DEPLOYED CONDITION. DURING TESTING, AFTER REMOVING THE DRIED BLOOD THAT HAD COAGULATED IN THE SHEATH OF THE DEVICE, THE GUIDE WIRE WAS INSERTED, PASSED THROUGH THE SHEATH, AND EXITED THE RAMP WITHOUT DIFFICULTY. BASED ON THE DEVICE EVALUATION, THE ROOT CAUSE FOR THE DIFFICULTY ENCOUNTERED TREADING THE GUIDE WIRE INTO THE DEVICE GUIDE WIRE EXIT PORT COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE DEVICE SUCCESSFULLY PERFORMED PRE-CLOSURE PLACEMENT OF THE PROSTAR XL SUTURES IN THE ARTERIOTOMY SITE PRIOR TO AN UNSPECIFIED INTERVENTIONAL PROCEDURE. IT WAS INITIALLY REPORTED THAT, "IT WAS EXTREMELY DIFFICULT TO FORWARD THE PROSTAR XL OVER THE GUIDE WIRE EVEN THOUGH THE DEVICE WAS USED SUCCESSFULLY." ADDITIONAL INFORMATION RECEIVED INDICATES THAT AFTER SUTURE PLACEMENT THE PHYSICIAN REPORTED, "THE GUIDE WIRE COULDN'T BE REPLACED" IN THE DEVICE. "THE WELL EXPERIENCED PHYSICIAN HAD TO THREAD THE BACKSIDE OF A .035INCH WIRE INTO THE GUIDE WIRE EXIT PORT" TO REPLACE THE PROSTAR XL WITH THE PROCEDURAL SHEATH TO CONTINUE WITH THE PLANNED INTERVENTIONAL PROCEDURE. AT THE CONCLUSION OF THE INTERVENTIONAL PROCEDURE, THE PRE-PLACED SUTURES WERE SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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-VASCULAR SOLUTIONS NA 88010-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention