BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING

    MDR report key: 22155730 · Received June 5, 2025

    Report

    Report Number
    2124215-2025-37162
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 20, 2025
    Report Date
    June 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729859581
    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

    G4 PREMARKET / 510(K) #: K141150, K162350. DEVICE EVALUATION BY MANUFACTURER: THE STERLING BALLOON CATHETER WAS RETURNED FOR ANALYSIS. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED NO DAMAGES. MICROSCOPIC EXAMINATION REVEALED A PINHOLE IN THE BALLOON 95MM FROM THE TIP. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS CONFIRMED THERE IS A PINHOLE IN THE BALLOON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 12 ATMOSPHERES FOR 1 MINUTE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 12 ATMOSPHERES FOR 1 MINUTE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462609 STERLING CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939031601110 0029967504 08714729859581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown