BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 17328152 · Received July 14, 2023

    Report

    Report Number
    2024168-2023-07560
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 28, 2023
    Report Date
    September 7, 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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL SEPARATION WAS CONFIRMED. THE REPORTED FOLD ON THE DISTAL TIP WAS UNABLE TO BE CONFIRMED DUE TO THE RETURNED DEVICE CONDITIONS (SEPARATION). THE SEPARATION OF THE DISTAL TIP WAS NOTED AT 1 MM DISTAL TO DISTAL END OF THE SENSOR CHIP ASSEMBLY. 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 INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FOLD ON THE DISTAL TIP. IT MAY BE POSSIBLE THE ANATOMICAL CONDITION CAUSED THE REPORTED ISSUE; HOWEVER, THIS COULD NOT BE CONFIRMED. BASED ON THE REPORTED INFORMATION, IT WAS REPORTED THAT A BALLOON WAS USED TO STRAIGHTEN THE DISTAL TIP. IT MAY BE POSSIBLE WHILE THE BALLOON HELD THE DISTAL TIP AGAINST THE WALL OF THE BLOOD VESSEL, EXCESSIVE FORCE WAS USED TO PULL THE PRESSUREWIRE TO STRAIGHTEN THE DISTAL TIP. IT MAY ALSO BE POSSIBLE WHILE THE BALLOON WAS INFLATED, THE PART OF THE FOLD WAS PUSHED FORWARD WHICH COULD STRETCH THE DISTAL TIP. BOTH POSSIBILITIES COULD COMPROMISE THE INTEGRITY OF THE DISTAL TIP WHICH COULD LEAD TO THE SEPARATION DURING WITHDRAWAL TO THE INSIDE OF THE CATHETER. HOWEVER, THIS COULD NOT BE CONFIRMED AS IT WAS BASED ON PROCEDURAL CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE PRESSUREWIRE X (PWX), WIRELESS WAS USED TO MEASURE A STENOSED LESION IN THE CIRCUMFLEX ARTERY. AFTER THE MEASUREMENT WAS PERFORMED (RFR > 0,89), THE PWX WAS PULLED BACK AND THE DISTAL TIP FOLDED BACK. A BALLOON WAS ADVANCED TO STRAIGHTEN THE TIP AND THE WIRE WAS ABLE TO BE PULLED BACK FURTHER TOWARDS THE CATHETER. HOWEVER, SHORTLY BEFORE THE DISTAL TIP REACHED THE CATHETER, THE PWX BROKE INTO TWO SEGMENTS. THE DISTAL TIP WAS ALREADY PARTLY IN THE CATHETER AND WAS SNARED WITH ANOTHER BALLOON AND WAS REMOVED SAFELY. THERE WAS NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208070 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR X 30216G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention