BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 6937225 · Received October 10, 2017

    Report

    Report Number
    2024168-2017-08108
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 10, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648138102
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: GUIDE WIRE: SIONBLUE, SION , GUIDE CATHETER: HYPERION 6FR SPB 3.5. DEVICE CODING: (B)(4)- INCORRECT PREP . THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT SHOULD BE NOTED THAT THE TREK RX AND MINI TREK RX GLOBAL INSTRUCTIONS FOR USE STATES: ALL AIR MUST BE REMOVED FROM THE BALLOON AND DISPLACED WITH CONTRAST PRIOR TO INSERTING INTO THE BODY, OTHERWISE, COMPLICATIONS MAY OCCUR. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE DISTAL CIRCUMFLEX. A 1.5X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE PRIOR TO USE AND AIR WAS PULLED INSIDE OF THE ANATOMY PRIOR TO USE. THE BDC WAS ADVANCED TO THE LESION; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. DURING PRE-DILATATION, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES. PRE-DILATATION WAS COMPLETED WITH A NON-ABBOTT BALLOON CATHETER FOLLOWED BY IMPLANTING A XIENCE ALPINE STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716983 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50617G2 08717648138102

    Patients

    Seq Age Sex Outcome Treatment
    1