BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUATRACK HYDROPHILIC NITINOL GUIDEWIRE

    MDR report key: 17410518 · Received July 27, 2023

    Report

    Report Number
    3007635982-2023-00002
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    March 3, 2023
    Report Date
    July 27, 2023
    Manufacturer
    CONFLUENT MEDICAL TECHNOLOGIES, INC.
    Product Code
    DQX
    PMA / PMN Number
    K011905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW FOR LOT 82258152 DID NOT IDENTIFY ANY UNUSUAL MANUFACTURING ISSUES THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. PHYSICAL ANALYSIS AND FAILURE MODE VERIFICATION COULD NOT BE PERFORMED, SINCE THE PRODUCT WAS NOT RETURNED TO CONFLUENT FOR ASSESSMENT. CONFLUENT SHIPS APPROXIMATELY (B)(4) AQUATRACK GUIDEWIRES PER YEAR. THIS COMPLAINT FOR AN EVENT DESCRIBED AS GUIDEWIRE BREAK, REPRESENTS THE FOURTH EVENT WITH SIMILAR FAILURE MODE DESCRIPTIONS IN THE PAST TWO YEARS. FAILURE MODE COULD NOT BE VERIFIED FOR ALL OF THEM, SINCE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT DOES NOT PRESENT UNACCEPTABLE RISKS IN THE FIELD OR WARRANT ADDITIONAL ACTIONS AT THIS TIME. CONCLUSION: INFORMATION PROVIDED IN CORDIS COMPLAINT# (B)(4), COMBINED WITH LACK OF PRODUCT RETURN FOR ANALYSIS, IS NOT SUFFICIENT TO VERIFY THE EVENT, OR IDENTIFY A ROOT CAUSE WITH ANY CERTAINTY. NO ADDITIONAL ACTIONS HAVE BEEN IDENTIFIED. THIS EVENT HAS BEEN INCLUDED IN CONFLUENT COMPLAINT DATABASE FOR USE IN ON-GOING TRENDING. IF THE GUIDEWIRE IN QUESTION IS RETURNED FOR ANALYSIS IN THE FUTURE, OR ADDITIONAL EVENT DETAILS ARE MADE AVAILABLE, THE COMPLAINT AND INVESTIGATION WILL BE RE-OPENED AT THAT TIME.

    Description of Event or Problem · 0

    AS REPORTED, AFTER PUNCTURING, THE END TIP OF THE 150CM AQUATRACK HYDROPHILIC GUIDEWIRE BROKE OFF INTO TWO PIECES IN THE RIGHT ILIAC VEIN DURING THE EXCHANGE OF THE GUIDEWIRE AND WAS REMOVED BY INCISION OF THE VESSEL. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT IS UNKNOWN IF THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE WIRE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. IT IS NOT KNOWN IF THE WIRE WAS RE-SHAPED BY THE USER. THE WIRE WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THE INTENDED PROCEDURE WAS REPORTED AS POSITIONING FROM THE RIGHT FEMORAL VEIN TO PLACE A STENT IN THE LEFT ILIAC VEIN. THE TARGET LESION WAS THE LEFT ILIAC VEIN. THE LESION CALCIFICATION AND PERCENTAGE STENOSIS ARE UNKNOWN. THERE WAS MODERATE VESSEL TORTUOSITY. IT IS UNKNOWN IF A "DRILLING" OR "JACK-HAMMER " TECHNIQUE WAS USED TO RECANALIZE THE VESSEL. THERE WAS DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL OR LESION. THE WIRE BEHAVED "NORMALLY" (THE TORQUE RESPONSE WAS GOOD). THERE WAS NO RESISTANCE/FRICTION BETWEEN THE WIRE AND OTHER DEVICES. THE STATUS OF THE PATIENT WAS REPORTED AS "NORMAL". THE EVENT CAUSED A RELEVANT CLINICALLY INCREASE IN THE DURATION OF THE PROCEDURE. THE EVENT CAUSED A CONDITION THAT REQUIRED HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919746 AQUATRACK HYDROPHILIC NITINOL GUIDEWIRE AQUATRACK HYDROPHILIC NITINOL GUIDEWIRE DQX CONFLUENT MEDICAL TECHNOLOGIES, INC. 82258152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization