BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 16707460 · Received April 10, 2023

    Report

    Report Number
    2024168-2023-03626
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    March 29, 2023
    Report Date
    May 16, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. IT WAS REPORTED BY THE ACCOUNT THAT THE PRESSUREWIRE INTERACTED WITH THE PATIENT ANATOMY RESULTING IN THE REPORTED DIFFICULTY ADVANCING THE DEVICE/EASE OF HANDLING AND UPON FURTHER MANIPULATION, AGAINST RESISTANCE, PORT OF THE WIRE BECAME TWISTED. THE PATIENT EXPERIENCED A DISSECTION, BUT IT IS UNKNOWN IF THE PRESSUREWIRE CONTRIBUTED TO IT OR IF IT WAS DUE TO THE MORPHOLOGY OF THE LESION. ADDITIONAL TREATMENT WITH A STENT WAS PERFORMED TO TREAT THE DISSECTION. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN THE PRESSUREWIRE INSTRUCTION FOR USE (ADVERSE EVENTS SECTION) AS A KNOWN POTENTIAL COMPLICATION WHICH MAY BE ENCOUNTERED DURING ALL CATHETERIZATION PROCEDURES. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE INVESTIGATION DETERMINED THE DIFFICULTY ADVANCING THE DEVICE, USE OF DEVICE PROBLEM, MATERIAL TWISTED/BENT AND UNEXPECTED MEDICAL INTERVENTION APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN ADVANCING THE PRESSUREWIRE X (PWX) TO THE LEFT CIRCUMFLEX ARTERY, RESISTANCE WAS FELT WITH THE ANATOMY. THE PWX CROSSED THE LESION BUT THE PROXIMAL PART OF THE WIRE GOT TWISTED AND A DISSECTION OCCURRED. THE DISSECTION WAS TREATED WITH A STENT. THE PHYSICIAN SAID THE DEVICE HAS POOR MANEUVERABILITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549854 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR X 20328G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention