BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 15439928 · Received September 16, 2022

    Report

    Report Number
    2024168-2022-09809
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 25, 2022
    Report Date
    November 2, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE DRAGONFLY OPTIS REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY TO REMOVE WAS NOT ABLE TO BE CONFIRMED AS IT WAS BASED ON PROCEDURAL CIRCUMSTANCES. THE REPORTED DEFORMATION WAS CONFIRMED AS THE DEVICE WAS NOTED TO HAVE BEEN TWISTED/BENT. 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 COMPLAINTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTY TO REMOVE RESULTING IN STRETCHED TIP COILS AND BREAK WERE LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT THE PRESSUREWIRE TIP WAS ENTRAPPED WITHIN THE HEAVY LESION CALCIFICATION AND/OR THE UNSPECIFIED STENT IN THE LEFT MAIN RESULTING IN STRETCHING OF THE TIP COILS AND BREAK AS THE WIRE WAS REMOVED WITH FORCE. THE PRESSUREWIRE X GUIDEWIRE INSTRUCTION FOR USE (IFU) WARNS THAT TORQUING OR EXCESSIVE MANIPULATION OF THE GUIDEWIRE IN A SHARP BEND, AGAINST RESISTANCE, OR REPEATED ATTEMPTS TO CROSS A TOTAL VESSEL OCCLUSION MAY RESULT IN VESSEL DISSECTION OR PERFORATION OF BLOOD VESSELS, VESSEL SPASM, DAMAGE AND / OR FRACTURE THE GUIDEWIRE. 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 THE PRESSUREWIRE X,(PWX) DEVICE WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY. THE LESION WAS SUCCESSFULLY TREATED WITH AN UNSPECIFIED BALLOON, SUBSEQUENT TO AN UNSPECIFIED STENT. THE PWX DEVICE REMAINED IN THE PATIENT AND THEN A DRAGONFLY OPTIS IMAGING CATHETER WAS ADVANCED TO THE TREATED LESION TO VERIFY PROPER STENT PLACEMENT. AFTER THE FIRST PULLBACK, THE RUN DID NOT LOOK RIGHT DUE TO UNINTENDED MOVEMENT OF A NON-ABBOTT GUIDE CATHETER THAT LED TO BLOOD FLOW TO SWIRL. THEREFORE, THE PWX DEVICE WAS ADVANCED FURTHER DISTALLY; HOWEVER, THE IMAGING CATHETER WAS STUCK WITH THE PWX DEVICE. BOTH THE PWX DEVICE AND IMAGING CATHETER WERE REMOVED AS A SINGLE UNIT. ONCE BOTH THE PWX DEVICE AND IMAGING CATHETER WERE OUTSIDE THE PATIENT, THE PWX DEVICE WAS ABLE TO BE SEPARATED FROM THE IMAGING CATHETER. IT WAS NOTED THAT THE TIP OF THE PWX DEVICE WAS EXTREMELY CURLED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874277 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR X 20513G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male