BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 21882011 · Received April 22, 2025

    Report

    Report Number
    2124215-2025-25303
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729796268
    PMA / PMN Number
    K111295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): DQY, LIT. G4 - PREMARKET / 510(K): K111295, K162350.

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): DQY, LIT. G4: PREMARKET/510(K): K111295, K162350. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED NO DAMAGES. MICROSCOPIC EXAMINATION REVEALED A PINHOLE 10 MM FROM THE TIP. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 3.0MM X 60MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THIRD INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. 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 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 3.0 MM X 60 MM X 150 CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THIRD INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353131 COYOTE? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H74939185300610 0033813071 08714729796268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown