BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 23678048 · Received December 1, 2025

    Report

    Report Number
    2124215-2025-87817
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 22, 2025
    Report Date
    December 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729859611
    PMA / PMN Number
    K141150
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K): K141150, K162350.

    Additional Manufacturer Narrative · 0

    B5 - DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. G4: PREMARKET / 510(K): K141150, K162350.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 6.0MMX150MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR 40 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 6.0MMX150MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR 40 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT NO PATIENT FACTORS CONTRIBUTED TO THE EVENT, AS THE VASCULAR COURSE WAS NORMAL. ADDITIONALLY, NO PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT BECAUSE NO ISSUES WERE NOTED AND THE PHYSICIAN HAD THOROUGH KNOWLEDGE OF IVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2801932 STERLING? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939031601610 0031797156 08714729859611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown