Coyote™ H74939186300810Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729796541), received between Feb 5, 2019 and Dec 14, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH TIBIAL ARTERY BLOCKAGE AND UNDERWENT BALLOON ANGIOPLASTY. AFTER GAINING VASCULAR ACCESS VIA THE FEMORAL ARTERY, A 3.0MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE BALLOON GOT STUCK ON A 300CM ANGLED TIP V-14 CONTROL WIRE GUIDEWIRE AND WOULD NOT MOVE FURTHER INTO THE TARGET LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976093 ↗
• MalfunctionJul 19, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT TIBIOPERONEAL TRUNK (TPT). A 3.0MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON CATHETER WAS ADVANCED DOWN THE 014 THRUWAY 300CM/SHORT TAPER/STRAIGHT WIRE, IT WAS NOTED THAT AS THE BALLOON GOT CLOSER TO THE TIP OF THE WIRE, THE WIRE BECAME STUCK IN THE WIRE LUMEN OF THE BALLOON. THE WIRE WAS ATTEMPTED TO BE REMOVED BUT FAILED; THEN BOTH THE WIRE AND BALLOON WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189574 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERONEAL ARTERY. A 300CM V-14 CONTROL WIRE WAS ADVANCED AND PLACED INTO THE LESION. HOWEVER, DURING REMOVAL THROUGH THE 3.0MM X 80MM X 150CM COYOTE BALLOON CATHETER LUMEN, THE COATING OF THE GUIDEWIRE SHEARED OFF AND WAS CONFIRMED DURING VISUAL INSPECTION. RESISTANCE WAS FELT DURING REMOVAL OF THE WIRE THROUGH THE BALLOON. THE PHYSICIAN REMOVED THE BALLOON CATHETER. THERE WAS GOOD DISTAL RUN-OFF FLOW IN THE PERONEAL ARTERY. AFTER THE INTERVENTION, THE PHYSICIAN DID ANOTHER DISTAL RUN-OFF OF THE PERONEAL ARTERY TO SEE IF THE COATING OCCLUDED THE VESSEL AND IT DID. THE PHYSICIAN PERFORMED BALLOON ANGIOPLASTY WHERE THE COATING WAS SITTING AND ANOTHER RUN-OFF WAS PERFORMED. GOOD BLOOD FLOW WAS ESTABLISHED. THE PEELED OFF COATING WAS NOT REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT HOME THE SAME DAY.

  Patient problems: Occlusion

  MAUDE report 10635666 ↗
• MalfunctionJun 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED POSTERIOR TIBIAL ARTERY. A 3.0MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 11 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181556 ↗
• MalfunctionFeb 5, 2019Entrapment of Device; Difficult to Advance; Material Deformation; Entrapment of Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE HIGHLY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ARTERIA TIBEALIS POSTERIOR ARTERY. AN ATTEMPT TO ADVANCE THE 3.0MM X 80MM X 150CM COYOTE OVER THE 300CM V-14 CONTROL WIRE WAS MADE; HOWEVER THE CATHETER STUCK ON THE WIRE AND THE BALLOON LOOKED LIKE AN ACCORDION. THE CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. ANOTHER OF THE SAME CATHETER AND GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8306623 ↗