BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

    MDR report key: 21540553 · Received March 6, 2025

    Report

    Report Number
    2124215-2025-09874
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    December 31, 2024
    Report Date
    March 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FROM NAJ TO DQY. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA USER FACILITY#: (B)(4) THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT RADIAL ARTERY. THE OCCLUDED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT RENAL ARTERY. THE PHYSICIAN DECIDED TO PURSUE LEFT FEMORAL ARTERY ACCESS BY PLACING 6F SHEATH AND 6F STEERABLE SHEATH. THE LESION WAS WIRED WITH NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE AND DILATED WITH 2 MM, 3 MM AND 5 MM NON-BSC BALLOON FOR 200 PULSES. A 6.0 MM X 40 MM X 135 CM (4F) STERLING BALLOON CATHETER WAS ADVANCED AND DILATED BUT THEN RUPTURED. THE SHEATH AND BALLOON WERE REMOVED INTACT AND REINSERTED. THE LESION WAS WIRED AGAIN WITH 6 MM ATHLETIS BALLOON, BUT IT DID NOT CROSS. THE IVUS SHOWS RESIDUAL SEVERE UNDEREXPANSION. THIS 6 MM NC CORONARY BALLOON WAS USED BUT RUPTURED, THEREFORE A 6 MM DRUG-COATED BALLOON WAS USED TO DILATE BUT STILL RESIDUAL WAIST WAS NOTED. THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA USER FACILITY#: (B)(4) THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT RADIAL ARTERY. THE OCCLUDED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT RENAL ARTERY. THE PHYSICIAN DECIDED TO PURSUE LEFT FEMORAL ARTERY ACCESS BY PLACING 6F SHEATH AND 6F STEERABLE SHEATH. THE LESION WAS WIRED WITH NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE AND DILATED WITH 2MM, 3MM AND 5MM NON-BSC BALLOON FOR 200 PULSES. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED AND DILATED BUT THEN RUPTURED. THE SHEATH AND BALLOON WERE REMOVED INTACT AND REINSERTED. THE LESION WAS WIRED AGAIN WITH 6MM ATHLETIS BALLOON, BUT IT DID NOT CROSS. THE IVUS SHOWS RESIDUAL SEVERE UNDEREXPANSION. THIS 6MM NC CORONARY BALLOON WAS USED BUT RUPTURED, THEREFORE A 6MM DRUG-COATED BALLOON WAS USED TO DILATE BUT STILL RESIDUAL WAIST WAS NOTED. THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313621 AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS DQY BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female