BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRUITT F3-S POLYURETHANE CAROTID SHUNT

    MDR report key: 22801377 · Received August 13, 2025

    Report

    Report Number
    1220948-2025-00138
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    May 28, 2025
    Report Date
    August 13, 2025
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MJN
    UDI-DI
    00840663108367
    PMA / PMN Number
    K152833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. THEREFORE, THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE DEVICE WAS CHECKED PRIOR TO USE, WHERE NO DEFICIENCIES WERE REPORTED. DUE TO REPORTS OF SIMILAR ISSUES FOR THIS PRODUCT, A CORRECTIVE AND PREVENTIVE ACTION (CAPA 2024-005) HAS BEEN IMPLEMENTED TO FURTHER INVESTIGATE AND ADDRESS THE REPORTED ISSUE. THE CAPA ADDED ADDITIONAL CONTROLS AROUND THE BALLOON MATERIAL STORAGE CONDITIONS AND SHELF LIFE OF THE BALLOON RAW MATERIAL. HOWEVER, BOTH DEVICES WERE MANUFACTURED IN 2023, PRIOR TO IMPLEMENTATION OF THE CAPA. BALLOON RUPTURE IS AN INHERENT RISK OF USING THIS PRODUCT. AS STATED IN THE IFU: "EXERCISE CAUTION WHEN ENCOUNTERING EXTREMELY DISEASED VESSELS. ARTERIAL RUPTURE OR BALLOON FAILURE DUE TO SHARP CALCIFIED PLAQUE MAY OCCUR. AVOID EXTENDED OR EXCESSIVE EXPOSURE TO FLUORESCENT LIGHT, HEAT, SUNLIGHT, OR CHEMICAL FUMES TO REDUCE BALLOON DEGRADATION." THE LOT HISTORY RECORD OF BOTH REPORTED LOT NUMBERS WERE REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE CUSTOMER IS UNSURE WHICH REPORTED LOT NUMBER WAS CORRECT. THE TWO POSSIBLE DEVICES ARE: LOT PFP1151, MANUFACTURE DATE: 230609, EXPIRATION DATE: 250528 LOT PFP1161, MANUFACTURE DATE: 231207, EXPIRATION DATE: 251128.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CEA PROCEDURE A NON-LATEX PRUITT F3 WAS USED. THE PHYSICIAN REPORTED THAT THE BALLOONS WERE INFLATED UNTIL THE POINT WHERE THERE WAS NO MORE BLOOD PASSING THE BALLOONS AND WITHIN THE MAXIMUM FILLING CAPACITY. DURING THE PROCEDURE THE INTERNAL BALLOON BURST. THIS CAUSED BLOOD LOSS, AND THE SHUNT HAD TO BE REPLACED. HOSPITAL UNSURE WHICH OF THE TWO LISTED PRODUCTS WAS THE FAULTY ONE AND WHICH WAS THE ONE THEY USED AS A REPLACEMENT. THE DEVICE WAS CHECKED PRIOR TO USE. NO OTHER COMPLICATIONS OR INJURIES REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782319 PRUITT F3-S POLYURETHANE CAROTID SHUNT POLYURETHANE CAROTID SHUNT MJN LEMAITRE VASCULAR, INC. PFP1151 00840663108367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention