BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA NC RX PTCA DILATATION CATHETER

    MDR report key: 3017340 · Received March 4, 2013

    Report

    Report Number
    3004036480-2013-00002
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 4, 2013
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS WERE REVIEWED AND THERE IS NO OBJECTIVE EVIDENCE TO SUGGEST THAT THE DEVICE MAY HAVE BEEN RELEASED WITH NONCONFORMITIES RELATED TO THE NATURE OF THIS COMPLAINT. THE DEVICE MET SPECS PRIOR TO DISTRIBUTION. ANALYSIS OF ACTUAL DEVICE IS PENDING.

    Description of Event or Problem · 1

    DURING USE OF AN EMPIRA NC RX PTCA 12X3.25 BALLOON FOR POST DILATATION, THE TEAM INFLATED THE BALLOON TO 14 ATMS FOR 10 SEC THEN IT BURST WHILE INSIDE PATIENT (WITHIN STENT). ON REMOVAL IT LOOKED LIKE THE PROXIMAL EDGE OF THE BALLOON WAS NOT ADHERED TO THE SHAFT (NOT FIXED). SAME LIKE PRODUCT USED TO COMPLETE PROCEDURE. THE TARGET LESION LOCATION WAS THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS A SIMPLE SINGLE LESION. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH A GUIDEWIRE. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON TO THE TARGET LESION. UPON INITIAL INFLATION, THE BALLOON RUPTURED. IT IS UNK WHAT TYPE OF INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THE BRAND OF CONTRAST USED IS UNK. THE CONTRAST TO SALINE RATIO WAS 50/50. NO PIECES OF THE BALLOON WERE LEFT IN THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92812 EMPIRA NC RX PTCA DILATATION CATHETER LOX, CATHETER, PTCA LOX CREGANNA-TACTX MEDICAL 75R12325N CE0000557

    Patients

    Seq Age Sex Outcome Treatment
    1