BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COYOTE?

    MDR report key: 22792414 · Received August 13, 2025

    Report

    Report Number
    2124215-2025-55495
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729796817
    PMA / PMN Number
    K111295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): DQY, LIT. G4: PREMARKET / 510(K) #: K103751, K110122.

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): DQY, LIT REPORTED HERE AS THE PRO CODE EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD G4: PREMARKET / 510(K): K103751, K110122 REPORTED HERE AS THE PMA/510K EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD DEVICE EVALUATED BY MFR: THE COYOTE WAS RETURNED FOR ANALYSIS. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE INFLATION LUMEN IS SEPARATED 71.3CM FROM THE HUB AND THE CORE WIRE IS KINKED AT THE SEPARATION. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THE MARKERBAND, BALLOON, TIP, AND DISTAL SECTION OF THE SHAFT ARE ALL MISSING. PRODUCT ANALYSIS FOUND DAMAGE TO THE DEVICE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FROZE ON WIRE OCCURRED AND ADDITIONAL INTERVENTION WAS PERFORMED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE PROCEDURE IDENTIFIED RESIDUAL STENOSIS, PROMPTING A POST-DILATATION WITH A PLAIN OLD BALLOON ANGIOPLASTY (POBA) AT THE MID-SECTION. FOLLOWING THE POBA, AN ATTEMPT WAS MADE TO WITHDRAW THE BALLOON CATHETER; HOWEVER, IT BECAME LODGED ALONG WITH THE JUPITER FC GUIDEWIRE. FURTHER EFFORTS TO ADVANCE THE GUIDEWIRE DISTALLY WERE UNSUCCESSFUL, AS IT REMAINED FIRMLY ENTRAPPED. AT THIS POINT, IT IS LIKELY THAT SIGNIFICANT DAMAGE OCCURRED TO THE GUIDEWIRE WHILE IT WAS STILL WITHIN THE PATIENT. DUE TO THE CHALLENGES ENCOUNTERED WITH THE IPSILATERAL APPROACH, THE PROCEDURE WAS TRANSITIONED TO A CONTRALATERAL APPROACH. THE BALLOON CATHETER WAS INTENTIONALLY RUPTURED AT THE HUB TO FACILITATE REMOVAL. USING A SNARE, THE INTEGRATED BALLOON CATHETER AND GUIDEWIRE WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FROZE ON WIRE OCCURRED AND ADDITIONAL INTERVENTION WAS PERFORMED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE PROCEDURE IDENTIFIED RESIDUAL STENOSIS, PROMPTING A POST-DILATATION WITH A PLAIN OLD BALLOON ANGIOPLASTY (POBA) AT THE MID-SECTION. FOLLOWING THE POBA, AN ATTEMPT WAS MADE TO WITHDRAW THE BALLOON CATHETER; HOWEVER, IT BECAME LODGED ALONG WITH THE JUPITER FC GUIDEWIRE. FURTHER EFFORTS TO ADVANCE THE GUIDEWIRE DISTALLY WERE UNSUCCESSFUL, AS IT REMAINED FIRMLY ENTRAPPED. AT THIS POINT, IT IS LIKELY THAT SIGNIFICANT DAMAGE OCCURRED TO THE GUIDEWIRE WHILE IT WAS STILL WITHIN THE PATIENT. DUE TO THE CHALLENGES ENCOUNTERED WITH THE IPSILATERAL APPROACH, THE PROCEDURE WAS TRANSITIONED TO A CONTRALATERAL APPROACH. THE BALLOON CATHETER WAS INTENTIONALLY RUPTURED AT THE HUB TO FACILITATE REMOVAL. USING A SNARE, THE INTEGRATED BALLOON CATHETER AND GUIDEWIRE WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763116 COYOTE? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H74939185202210 0036080161 08714729796817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention INTRODUCER SHEATH - MEDIKIT PARENT SELECT 5082.| INTRODUCER SHEATH - MEDIKIT PARENT SELECT 5082.