BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA NC RX PTCA DILATATION CATHETER

    MDR report key: 2316581 · Received October 6, 2011

    Report

    Report Number
    3008950987-2011-00002
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Date of Event
    August 11, 2011
    Report Date
    October 6, 2011
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MAY BE RETURNED. AWAITING CONFIRMATION FROM SITE. MFG RECORDS WERE REVIEWED AND THERE WAS NO EVIDENCE TO SUGGEST THE DEVICE MAY HAVE BEEN RELEASED WITH NON-CONFORMITIES RELATED TO THE NATURE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    THE PHYSICIAN USED AN EMPIRA NC 15X3.00 ON A HIGHLY CALCIFIED LESION TO PRE-DILATE THE LESION. THE SAME EMPIRA NC WAS USED TO POST-DILATE THE DRUG-ELUTING STENT (DES). WHILE INFLATING THE BALLOON TO POST-DILATE, THE DISTAL SEGMENT BROKE OFF. THE SHAFT BROKE APART AT THE RX PORT AND COMPLETELY SEPARATED. BOTH INFLATIONS WERE TO 18 ATM. THE PHYSICIAN TRIED TO NOT MOVE THE BALLOON ON THE GUIDEWIRE DURING INFLATION. THE PHYSICIAN USED A GOOSENECK EV3 SNARE TO PUNCTURE AND RETRIEVE THE BALLOON. THE PHYSICIAN CARRIED OUT THE CASE WITH A DURA STAR WITH NO ISSUES. NO ADVERSE PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA NC RX PTCA DILATATION CATHETER PRODUCT CODE: LOX, CATHETERS PTCA LOX CREGANNA-TACTX MEDICAL 75R15300N CE0000104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention