BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COYOTE ES

    MDR report key: 22338978 · Received June 26, 2025

    Report

    Report Number
    2124215-2025-39614
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    May 30, 2025
    Report Date
    July 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729767206
    PMA / PMN Number
    K093636
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED D4 LOT NUMBER: 0035411892 UPDATED D4 EXPIRATION DATE: 12/03/2027 DEVICE EVALUATION BY MANUFACTURER: THE COYOTE ES BALLOON WAS RETURNED FOR ANALYSIS. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE GUIDEWIRE LUMEN AND INFLATION LUMEN IS SEPARATED 24.2CM FROM THE TIP. THERE ARE MULTIPLE KINKS ALONG THE SHAFT. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS CONFIRMED A SEPARATION AND DAMAGES THAT WOULD HAVE CONTRIBUTED TO THE DIFFICULTY TO ADVANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT WAS DETACHED, REQUIRING INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE WIRE PASSED THROUGH THE LESION AND WAS WIDENED WITH A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER. SUBSEQUENTLY, THE SHAFT WAS MOVED TO ANOTHER LESION FOR PLAIN OLD BALLOON ANGIOPLASTY, BUT THERE WAS RESISTANCE ENCOUNTERED. FURTHER INFLATION AND DEFLATION WAS PERFORMED, AND THE SHAFT WAS PULLED. UPON PULLING THE SHAFT, IT WAS CONFIRMED THAT IT WAS DETACHED. A SNARE WAS USED TO RETRIEVE THE DETACHED PART, AND NO FOREIGN OBJECTS WERE LEFT IN THE BODY. 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 SHAFT WAS DETACHED, REQUIRING INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE WIRE PASSED THROUGH THE LESION, AND WAS WIDENED WITH A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER. SUBSEQUENTLY, THE SHAFT WAS MOVED TO ANOTHER LESION FOR PLAIN OLD BALLOON ANGIOPLASTY, BUT THERE WAS RESISTANCE ENCOUNTERED. FURTHER INFLATION AND DEFLATION WAS PERFORMED, AND THE SHAFT WAS PULLED. UPON PULLING THE SHAFT, IT WAS CONFIRMED THAT IT WAS DETACHED. A SNARE WAS USED TO RETRIEVE THE DETACHED PART, AND NO FOREIGN OBJECTS WERE LEFT IN THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187633 COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION H74939135152010 0035411892 08714729767206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention