BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTA PRO PTA DILATATION CATHETER

    MDR report key: 1021162 · Received March 27, 2008

    Report

    Report Number
    9610978-2008-00083
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 19, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AFTER THE PROCEDURE, THERE WAS DIFFICULTY EXPERIENCED WITHDRAWING THE OPTA PRO PTA DILATATION CATHETER THROUGH THE CATHETER SHEATH INTRODUCER (CSI); THEREFORE, THE PHYSICIAN REMOVED THE CATHETER AND CSI TOGETHER. HOWEVER, WHILE OBSERVING THE PRODUCT AND IMAGES, IT WAS NOTICED THAT PART OF THE BALLOON MATERIAL SEPARATED IN THE VESSEL. THE MATERIAL WAS SURGICALLY REMOVED. THE PHYSICIAN WAS PERFORMING A CONTRALATERAL INTERVENTION VIA RIGHT ACCESS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTA PRO PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention