BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 21841062 · Received April 15, 2025

    Report

    Report Number
    2124215-2025-23359
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    February 8, 2025
    Report Date
    August 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806301
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). G4: PREMARKET / 510(K) #K163174. THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT IDENTIFIED A BREAK LOCATED 41 CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. ADDITIONALLY, MULTIPLE KINKS WERE OBSERVED ALONG THE HYPOTUBE. EXAMINATION OF THE INNER LUMEN AND MIDSHAFT SECTIONS REVEALED NO ISSUES. MICROSCOPIC ANALYSIS OF THE BALLOON CONES SHOWED NO DEFECTS, AND NO PINHOLES OR TEARS WERE IDENTIFIED IN THE BALLOON. THE BUMPER TIP WAS INTACT, WITH NO SIGNS OF DAMAGE. A FUNCTIONAL TEST WAS CONDUCTED DESPITE THE HYPOTUBE BREAK. THE DEVICE WAS CONNECTED TO AN INFLATION AID, AND THE BALLOON WAS INFLATED WITHOUT ISSUE TO ITS RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES. THE BALLOON FULLY INFLATED AND MAINTAINED PRESSURE FOR 15 SECONDS WITH NO LEAKS OBSERVED. A VACUUM WAS APPLIED, AND THE BALLOON DEFLATED COMPLETELY WITHOUT RESISTANCE. THIS INFLATION AND DEFLATION CYCLE WAS REPEATED THREE ADDITIONAL TIMES, WITH NO ISSUES NOTED. NO OTHER DEVICE ISSUES WERE IDENTIFIED DURING THE RETURNED PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 0

    (B)(6). G4: PREMARKET / 510(K) #K163174. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE DEVICE WAS DELIVERED TO THE TARGET SITE BUT FAILED TO INFLATE. UPON WITHDRAWAL, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE DEVICE WAS DELIVERED TO THE TARGET SITE BUT FAILED TO INFLATE. UPON WITHDRAWAL, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113092 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918920200 0034680806 08714729806301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown