BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE ES

    MDR report key: 18486365 · Received January 10, 2024

    Report

    Report Number
    2124215-2023-75683
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 13, 2023
    Report Date
    February 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729767329
    PMA / PMN Number
    K093636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR.: THE RETURNED PRODUCT CONSISTED OF A COYOTE ES BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED NO DAMAGES. MICROSCOPIC EXAMINATION REVEALED A HOLE IN THE SHAFT 51.2CM FROM THE HUB. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRE PERFORATED THE DEVICE. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE OF THE POSTERIOR TIBIAL ARTERY. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS ADVANCED WITH JUPITER FC GUIDEWIRE AS A SUPPORT CATHETER. AFTER THAT, IN ORDER TO REPLACE IT WITH JUPITER SFC GUIDEWIRE, THE FC WIRE WAS REMOVED WHILE LEAVING THE DEVICE IN THE BLOOD VESSEL AND REPLACED WITH SFC WIRE. WHILE ADVANCING THE SFC WIRE TO THE GUIDEWIRE LUMEN OF THE CORRESPONDING DEVICE, THE GUIDEWIRE LUMEN WAS PIERCED AND THE SFC GOT INTO THE BLOOD VESSEL. THE BALLOON AND ENTIRE GUIDEWIRE WERE REMOVED, AND THE SFC WIRE WAS CONFIRMED TO HAVE PENETRATED THE BALLOON SHAFT. THE PROCEDURE WAS PERFORMED USING THE SAME SYSTEM, RESULTING IN SUCCESSFUL REVASCULARIZATION. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRE PERFORATED THE DEVICE. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE OF THE POSTERIOR TIBIAL ARTERY. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS ADVANCED WITH JUPITER FC GUIDEWIRE AS A SUPPORT CATHETER. AFTER THAT, IN ORDER TO REPLACE IT WITH JUPITER SFC GUIDEWIRE, THE FC WIRE WAS REMOVED WHILE LEAVING THE DEVICE IN THE BLOOD VESSEL AND REPLACED WITH SFC WIRE. WHILE ADVANCING THE SFC WIRE TO THE GUIDEWIRE LUMEN OF THE CORRESPONDING DEVICE, THE GUIDEWIRE LUMEN WAS PIERCED AND THE SFC GOT INTO THE BLOOD VESSEL. THE BALLOON AND ENTIRE GUIDEWIRE WERE REMOVED, AND THE SFC WIRE WAS CONFIRMED TO HAVE PENETRATED THE BALLOON SHAFT. THE PROCEDURE WAS PERFORMED USING THE SAME SYSTEM, RESULTING IN SUCCESSFUL REVASCULARIZATION. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2548587 COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 24701 0031124986 08714729767329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDEWIRE: JUPITER FC AND SFC| GUIDEWIRE: JUPITER FC AND SFC