BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1003237 · Received February 21, 2008

    Report

    Report Number
    2020394-2008-00028
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT BEEN RETURNED FOR EVAL. IT IS UNK IF PT OR PROCEDURAL FACTORS CONTRIBUTED TO THIS EVENT. BASED ON THE INFO RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE IFU (INFORMATION FOR USE) FOR THIS PRODUCT STATES THE FOLLOWING: WARNING: IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. APPLYING EXCESSIVE FORCE TO THE CATHETER CAN RESULT IN TIP BREAKAGE OR BALLOON SEPARATION. PRECAUTIONS: IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER, IT IS RECOMMENDED TO REMOVE THE BALLOON CATHETER AND GUIDEWIRE/INTRODUCER SHEATH AS A SINGLE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON CATHETER COULD NOT BE RETRIEVED FROM THE SHEATH. THE USER RETRIEVED BOTH, THE SHEATH AND THE BALLOON CATHETER. THE PROCEDURE WAS BEING PERFORMED IN THE ILIAC WITH A RIGHT FEMORAL APPROACH. A 6F, 11CM INTRODUCER SHEATH WAS USED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. 93KR0073

    Patients

    Seq Age Sex Outcome Treatment
    1