Coyote™ H74939185401510Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 08714729797098), received between Aug 31, 2018 and Feb 20, 2026 — classified as 1 injury, 58 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (55 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400548 ↗
• MalfunctionDec 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873377 ↗
• MalfunctionNov 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS SEQUENTIALLY INFLATED TO 14, 14, 14, AND 10 ATMOSPHERES. DURING THE FOURTH INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615818 ↗
• MalfunctionOct 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334747 ↗
• MalfunctionJun 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292192 ↗
• MalfunctionMay 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071372 ↗
• MalfunctionFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ILIAC ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 10 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381707 ↗
• MalfunctionDec 12, 2024Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK WITH THE WIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR ENDOVASCULAR THERAPY PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS INSERTED AND BECAME STUCK WITH THE JUPITER FC3 GUIDEWIRE. BOTH THE BALLOON AND THE WIRE WERE REMOVED OUT OF THE BODY AS ONE UNIT. THE PROCEDURE WAS CANCELED DUE TO THE CONDITION OF THE LESION, WHICH MADE IT DIFFICULT FOR THE WIRE AND BALLOON TO CROSS. THE PHYSICIAN DETERMINED THAT IT WAS DIFFICULT TO CONTINUE WITH THE PROCEDURE EVEN IF THE DEVICE IS REPLACED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915846 ↗
• MalfunctionSep 25, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON GOT STUCK IN THE GUIDEWIRE LUMEN. AN ENDOVASCULAR THERAPY WAS PERFORMED FOR THE CHRONIC TOTAL OCCLUSION (CTO) FROM THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS USED SELECTED FOR TREATMENT. AFTER PASSING THE GUIDEWIRE, THE DEVICE WAS INFLATED BEFORE IT WAS REMOVED. DURING THE PROCEDURE, WHEN INSERTING INTO THE SHEATH AFTER IMAGING, THE DEVICE GOT STUCK IN THE GUIDEWIRE LUMEN AND COULD NOT BE RE-INSERTED INTO THE SHEATH. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300710 ↗
• InjuryJul 18, 2024Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM, COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, DEVICE WAS INFLATED TO EXPAND THE ARTERY ROUTE, BUT IT RUPTURED UPON SECOND TO THIRD INFLATION DURING INSERTION AND REMOVAL ATTEMPTS. THE TIP OF THE BALLOON WAS SEPARATED IN THE BODY AROUND 10CM. AN ELUVIA SELF-EXPANDING STENT WAS USED TO ENTRAP THE DETACHED COMPONENT IN THE VESSEL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19772629 ↗
• MalfunctionMay 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT AN ENDOVASCULAR THERAPY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE CATHETER BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 6 ATMOSPHERES FOR 1 SECOND, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM WHERE IT WAS NOTED THAT THE RUPTURE WAS THE SHAPE OF A PINHOLE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319424 ↗
• MalfunctionFeb 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, UPON FIRST INFLATION FOR 12 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18781496 ↗
• MalfunctionSep 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM MR COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 14 ATMOSPHERES FOR SEVERAL SECONDS, THE BALLOON RUPTURED IN A VERTICAL FORM AND A DAMAGED SURFACE APPEARED ON THE MAIN UNIT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842776 ↗
• MalfunctionSep 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788669 ↗
• MalfunctionJun 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FOURTH INFLATION AT 14 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175044 ↗
• MalfunctionJun 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17168061 ↗
• MalfunctionJun 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION AT 6 ATMOSPHERES FOR 1 SECOND, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17091509 ↗
• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM, COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS, THE BALLOON DISTAL PART RUPTURED NEAR THE SHOULDER. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND PATIENT CONDITION WAS GOOD AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083118 ↗
• MalfunctionMay 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878369 ↗
• MalfunctionFeb 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED FEMOROPOPLITEAL ARTERY BYPASS. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427965 ↗
• MalfunctionDec 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH LOWER EXTREMITY ARTERIAL DISEASE AND UNDERWENT ENDOVASCULAR THERAPY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000555 ↗
• MalfunctionNov 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724927 ↗
• MalfunctionOct 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED AT DISTAL PART. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611076 ↗
• MalfunctionOct 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT BASILIC VEIN. A 5F INTRODUCER SHEATH WAS INSERTED AND THE LESION PART WAS CROSSED WITH 0.014 GUIDEWIRE. A 4.0MM X 150MM X 150CM, MR COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND DILATATION WAS THEN PERFORMED USING THE SEPARATELY PREPARED 3MMX15CM COYOTE BALLOON CATHETER. INFLATION WAS THEN PERFORMED UP TO 14 ATMOSPHERES AND GOOD DILATATION HAS BEEN OBTAINED; THUS, THE PROCEDURE WAS COMPLETED AFTER CONTRAST CONFIRMATION. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576966 ↗
• MalfunctionSep 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498709 ↗