BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 21384983 · Received February 14, 2025

    Report

    Report Number
    2124215-2025-08486
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 23, 2025
    Report Date
    April 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K): K163174. DEVICE EVALUATED BY MFR: FG EMERGE MR, US 4.00MM X 8MM BALLOON CATHETER WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE INSPECTION IDENTIFIED MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO ISSUES. THE INNER LUMEN WAS STRETCHED AND PROLAPSED, 5CM FROM THE DISTAL TIP WHICH PUNCTURED THE OUTER LUMEN 5.3CM FROM THE TIP. TIP SHOWED NO SIGNS OF TIP DAMAGE. A MICROSCOPIC EXAMINATION OF THE DISTAL AND PROXIMAL MARKERBANDS IDENTIFIED NO DAMAGE. A LEAKAGE TESTING WAS PERFORMED WHEREIN THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION DEVICE. A LEAK WAS IDENTIFIED COMING FROM THE PUNCTURED OUTER LUMEN, 5.3CM FROM THE DISTAL TIP. THE ENCORE DEVICE VERIFIED BEFORE AND AFTER USE USING THE DRUCK GAUGE. NO OTHER DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K): K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A HOLE IN THE BALLOON. DURING PREPARATION OF A 4.00MM X 8MM EMERGE BALLOON CATHETER, THE PHYSICIAN NOTICED THAT AIR WAS PULLING INTO THE BALLOON, AND HOLE IN THE BALLOON WAS ALSO NOTED. THE PROCEDURE WAS COMPLETE WITH AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A HOLE IN THE BALLOON. DURING PREPARATION OF A 4.00MM X 8MM EMERGE BALLOON CATHETER, THE PHYSICIAN NOTICED THAT AIR WAS PULLING INTO THE BALLOON, AND HOLE IN THE BALLOON WAS ALSO NOTED. THE PROCEDURE WAS COMPLETE WITH AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414828 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918908400 0033419471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown