BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACIFIC XTREME

    MDR report key: 3811740 · Received May 15, 2014

    Report

    Report Number
    3004066202-2014-00076
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    November 25, 2013
    Report Date
    June 27, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K103464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS/ CONCLUSIONS: INHERENT RISK OF PROCEDURE (RESTENOSIS). (B)(4).

    Description of Event or Problem · 1

    DURING AN INTERVENTION PROCEDURE TWO PACIFIC PTA BALLOONS WERE USED TO TREAT STENOSIS OF THE RIGHT SFA. APPROXIMATELY FIVE MONTHS LATER THE PATIENT UNDERWENT REVASCULARIZATION AS TREATMENT FOR RESTENOSIS OF THE RIGHT SFA. PATIENT WAS TREATED WITH ONE PACIFIC PTA DEVICE AND ONE IN.PACT PACIFIC DEB. EVENT WAS RESOLVED.

    Description of Event or Problem · 1

    TWO PACIFIC PTA BALLOONS, THREE IN.PACT PACIFIC DRUG ELUTING BALLOONS AND ONE SCUBA STENT WERE USED DURING THE PREVIOUSLY REPORTED REVASCULARIZATION OF THE RIGHT SFA WHICH OCCURRED APPROX 12 MONTHS POST INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290378 PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention