BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUATRACK HYDROPHILIC NITINOL GUIDEWIRE

    MDR report key: 15180452 · Received August 5, 2022

    Report

    Report Number
    3007635982-2022-00002
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    May 16, 2022
    Report Date
    August 4, 2022
    Manufacturer
    CONFLUENT MEDICAL TECHNOLOGIES
    Product Code
    DQX
    PMA / PMN Number
    K011905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW FOR REPORTED LOT 82223759 IDENTIFIED, NO MANUFACTURING ISSUES OR PROCESS DEVIATIONS THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE LOT HAS NOT BEEN INVOLVED IN ANY PREVIOUS COMPLAINTS. PHYSICAL ANALYSIS AND FAILURE MODE VERIFICATION COULD NOT BE PERFORMED, SINCE THE PRODUCT WAS NOT RETURNED TO CONFLUENT FOR ASSESSMENT. BASED ON THE LIKELIHOOD THAT THE REPORTED EVENT DESCRIPTION OF "WIRE DIDN'T REMAIN IN ONE PIECE" IS ATTEMPTING TO DESCRIBE A SHEARING OF THE COATED JACKET MATERIAL FROM THE BARE WIRE, WHICH WAS SEEN IN A PREVIOUS COMPLAINT EXPERIENCE FROM 2018 IN WHICH A METAL ENTRY NEEDLE WAS ACTUALLY RETURNED WITH A GUIDEWIRE EXHIBITING SHEARED JACKET DAMAGE, THE ROOT CAUSE FOR THIS EVENT MAY BE DUE TO INTERFACE WITH A SHARP OR METALLIC DEVICE DURING THE PROCEDURE. IF SO, THIS WOULD BE COUNTER TO THE AQUATRACK IFU WARNINGS, WHICH IS PROVIDED IN MULTIPLE LANGUAGES. UNTIL SUCH TIME AS THE PRODUCT IS RETURNED FOR ANALYSIS, OR ADDITIONAL EVENT DETAILS ARE PROVIDED, THIS CAN ONLY BE CONSIDERED REASONABLE SPECULATION, BASED ON PREVIOUS EXPERIENCE. BASED ON REVIEW OF THE PAST 2 YEARS OF AQUATRACK FIELD COMPLAINTS, THE SAO PAULO CUSTOMER AT THE INITIAL REPORTING SITE FOR THIS EVENT HAS SUBMITTED 38% OF ALL AQUATRACK COMPLAINTS WORLDWIRE IN THAT TIME PERIOD, WITH PREVIOUS SEPARATE COMPLAINTS FOR JACKET SHEARING, DIFFICULTY ADVANCING A CATHETER OVER THE GUIDEWIRE, AND JACKET DAMAGED DURING USE. CORDIS HAS BEEN ASKED TO REVIEW PREVIOUS HISTORY WITH THIS CUSTOMER, TO DETERMINE IF ADDITIONAL COMMUNICATIONS, TRAINING OR ACTIONS SPECIFIC TO THIS CUSTOMER ARE WARRANTED. CONFLUENT SHIPS APPROXIMATELY 100,000 AQUATRACK GUIDEWIRES PER YEAR TO CORDIS, WHO IS FOR FINAL CUSTOMER SALES AND SHIPMENTS. THIS COMPLAINT FOR JACKET DAMAGE POSSIBLY DUE TO USER NOT FOLLOWING THE IFU WARNINGS, REPRESENTS THE FIFTH EVENT WITH SIMILAR FAILURE MODE IN THE PAST TWO YEARS, WITH TWO, INCLUDING THIS ONE, FROM THE SAME SITE IN SAO PAULO, BRAZIL. THE RESULTANT 2-YEAR EVENT RATE OF 5 IN 200,000 (0.0025%) FOR JACKET DAMAGE DURING THE PROCEDURE, DOES NOT PRESENT UNACCEPTABLE RISKS OR WARRANT ADDITIONAL ACTIONS AT THIS TIME

    Description of Event or Problem · 0

    AS REPORTED BY THE EVENT SITE IN (B)(6): "THE AQUATRACK´S GUIDEWIRE BROKE INTRAPROCEDURE DURING DRAINAGE OF AN INTRAPERITONEAL COLLECTION. WHEN ATTEMPTING TO PASS THE BILIARY DRAIN GUIDEWIRE, IT WAS NOTICED THAT WHEN IT WAS REMOVED, THE WIRE DIDN´T RETURN IN ONE PIECE, REMAINING 1CM, APPROXIMATELY, IN THE ABDOMINAL CAVITY (LEFT FLANK). THE PATIENT WASN´T INJURED.". THERE WAS NO RESPONSE FROM EVENT SITE TO REQUESTS FOR ADDITIONAL FOLLOW-UP INFORMATION OR DETAILS WERE PROVIDED. PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929664 AQUATRACK HYDROPHILIC NITINOL GUIDEWIRE AQUATRACK HYDROPHILIC NITINOL GUIDEWIRE DQX CONFLUENT MEDICAL TECHNOLOGIES 82223759

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown