BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 15670940 · Received October 25, 2022

    Report

    Report Number
    2024168-2022-11042
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    October 11, 2022
    Report Date
    October 25, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 REVEALED NO OTHER SIMILAR COMPLAINTS. IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE PRESSUREWIRE. THE REPORTED PATIENT EFFECTS OF EMBOLISM, SERIOUS ARRHYTHMIAS, AND CONGESTIVE HEART FAILURE ARE LISTED IN THE PRESSUREWIRE INSTRUCTION FOR USE AS KNOWN POTENTIAL COMPLICATIONS WHICH MAY BE ENCOUNTERED DURING ALL CATHETERIZATION PROCEDURES. INFORMATION FROM THE FIELD STATED THAT THE PRESSUREWIRE WAS USED WITH A GUIDING CATHETER SMALLER THAN 6F. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) DIRECTS THE USER TO USE THE PRESSUREWIRE GUIDEWIRE IN CONJUNCTION WITH A 6F (2 MM DIAMETER) GUIDING CATHETER. A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE UNEXPECTED MEDICAL INTERVENTION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PRESSUREWIRE X, WIRELESS WAS USED FOR SPASM EXAMINATION. THE EXAMINATION WAS PERFORMED WITHOUT ERGONOVINE. ALTHOUGH ELECTROCARDIOGRAM CHANGES WERE OBSERVED, THERE WERE NO ABNORMALITIES IN IMAGING AND CHEST PAIN FINDINGS, SO A CORONARY FLOW RESERVE EXAMINATION WAS PERFORMED. THE PWX CALIBRATED AND EQUALIZED NORMALLY. A <6F SHEATH WAS USED. THE DEVICE WAS INSERTED NEAR THE LEFT ANTERIOR DESCENDING MID LESION (BEFORE THE DISTAL). THE DEVICE WAS PURGED WITH SALINE WITH AN INJECTOR TO REMOVE THE CONTRAST IN THE DEVICE. BEFORE AND AFTER PURGING, VENTRICULAR FIBRILLATION OCCURRED. THE PATIENT WENT INTO CARDIAC ARREST; CARDIAC MASSAGE WAS PERFORMED IMMEDIATELY TO RESTORE THE HEART RATE, CONSCIOUSNESS, AND BLOOD PRESSURE. THE SYSTEM WAS COMPLETELY REMOVED, AND THE SHEATH WAS REINSERTED FROM THE OTHER SIDE (LEFT HAND), CORONARY ANGIOGRAM WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN COMMENTED THAT WHEN CONSIDERING THE DEVICE POSITION, IT IS DIFFICULT TO IMAGINE WIRE IRRITATION, SO IT IS BELIEVED THAT THERE WAS A DELAYED SPASM OR AIR WAS DRAWN INTO THE CATHETER WHILE MANIPULATING THE Y-CONNECTOR AFTER THE PWX ENTERED THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509152 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR X 20510G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R SHEATH SIZE:<6F