BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT BALANCE GUIDE WIRE

    MDR report key: 9666156 · Received February 4, 2020

    Report

    Report Number
    2024168-2020-01168
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    December 21, 2019
    Report Date
    April 2, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K021228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL AND DIMENSIONAL INSPECTION WERE PERFORMED ON THE RETURNED GUIDE WIRE AND THE REPORTED DIFFICULTY TO ADVANCE AND REMOVE WERE CONFIRMED AS THE GUIDE WIRE WAS RETURNED FROZEN IN THE GUIDE WIRE LUMEN. 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 IDENTIFIED NO OTHER SIMILAR INCIDENTS AND/OR COMPLAINTS REPORTED FROM THIS LOT. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULT TO ADVANCE AND DIFFICULT TO REMOVE THE GUIDE WIRE APPEARS TO BE RELATED TO OPERATIONAL CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.A2, A3, A4: CORRECTION - PATIENT AGE, SEX AND WEIGHT WERE PROVIDED. B7: CORRECTION - PATIENT INFORMATION PROVIDED. D4: CORRECTION - LOT AND PART NUMBER FROM UNK TO PART NUMBER 1001780J-HC AND LOT NUMBER 9090971

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT A PREDILATATION BALLOON WAS LOADED OVER THE BMW GUIDE WIRE. PREDILATATION WAS PERFORMED IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. THE XIENCE PROA SDS WAS STUCK BECAUSE OF RESISTANCE WITH THE BMW GUIDE WIRE. THE SDS WAS UNABLE TO BE REMOVED FROM THE GUIDE WIRE; THEREFORE, THE WIRE AND SDS WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY IN THE LCX. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE XIENCE PROA DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE XIENCE PROA REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3.5X12 MM XIENCE PROA STENT DELIVERY SYSTEM (SDS) WAS LOADED ON THE BALANCE MIDDLE-WEIGHT GUIDEWIRE. THE SDS BECAME STUCK DURING ADVANCEMENT AND COULD NOT GO ON. THE GUIDE WIRE AND THE SDS WERE REMOVED TOGETHER AS A UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129864 HT BALANCE GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 9090971

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR XIENCE PROA DES 3.50 X 12 RX CE| XIENCE PROA DES 3.50 X 12 RX CE