Coyote™ H74939186301510Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729796589), received between Nov 21, 2018 and Nov 17, 2025 — classified as 10 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24OCT2025. IT WAS REPORTED THAT BALLOON DID NOT INFLATE EVENLY AT NOMINAL THE TARGET LESION WAS LOCATED IN A VESSEL OF BELOW THE KNEE. A 3.0MM X 150MM X 150CM COYOTE WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TWICE AT NOMINAL PRESSURE FOR 30 SECONDS, HOWEVER THE DEVICE DID NOT INFLATE EVENLY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568086 ↗
• MalfunctionMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT LOWER LIMB ANGIOPLASTY PROCEDURE. A 3.0MM X 150MM X 150CM, OTW COYOTE? BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS INFLATED TO 6 ATMOSPHERES AND WAS RUPTURE TO GREATER THAN THE NOMINAL PRESSURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090760 ↗
• MalfunctionMar 20, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK ON WIRE. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE LOWER LEG VESSEL. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED THROUGH 6X45 NON-BOSTON SCIENTIFIC (BSC) SHEATH. THE LESION WAS DILATED AT 6 ATMOSPHERES FOR 2 MINUTES. DURING DEVICE REMOVAL, THE BALLOON BECAME STUCK ON THE NON-BSC WIRE. THE DEVICE WAS ATTEMPTED TO ADVANCED AND PULLED BACK, BUT THE BALLOON STARTED TO STRETCH ON THE WIRE. SUBSEQUENTLY, EVERYTHING WAS PULLED OUT AND THEN USED A NON-BSC BALLOON TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653033 ↗
• MalfunctionDec 17, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 3.0MM X 150MM X 150CM COYOTE CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. A 3MM X 150MM COYOTE BALLOON WAS USED SUCCESSFULLY DURING THE FIRST ANGIOPLASTY. AFTER BEING REMOVED TO CANNULATE THE ANTERIOR TIBIAL ARTERY, THE BALLOON RUPTURED WHEN REINSERTED DUE TO COMING OUT BETWEEN THE CATHETER AND BALLOON. THE BALLOON WAS PURGED OUTSIDE THE PATIENT, REVEALING A LEAK IN THE MIDDLE SECTION. A VISIBLE PUNCTURE WAS FOUND ON THE BALLOON, AND IT WAS REPLACED WITH A NEW ONE. NO GUIDE CATHETER WAS USED DURING THE PROCEDURE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20955853 ↗
• MalfunctionNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND A NEWLY OPENED BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE DISTAL SFA/POPLITEAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724416 ↗
• MalfunctionOct 25, 2024Poor Visibility; Poor Visibility

  IT WAS REPORTED THAT THE RADIOMARKER WAS NOT CONFIRMED ON THE SCREEN. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE DEVICE WAS DEPLOYED TO RELIEVE THE PATIENT'S VASCULAR STENOSIS. HOWEVER, THE RADIOMARKER WAS NOT VISIBLE ON THE SCREEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535252 ↗
• MalfunctionAug 22, 2024Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. THE 50% STENOSED, WHICH WAS APPROXIMATELY 2.5 CM X 100 MM IN SIZE, SOFT AND STRAIGHT TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING TO THE POPLITEAL ARTERY. A 3.0MM X 150MM X 150CM COYOTE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON APPEARED TO INFLATE IN CERTAIN AREAS BUT FAILED TO INFLATE IN OTHERS. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON FOR 5 MINUTES, BUT THE ANGIOGRAM SHOWED THAT IT WAS NOT DEFLATING. THE PHYSICIAN USED A 60-CC SYRINGE TO PULL NEGATIVE PRESSURE TO THE BALLOON, WHICH RESULTED IN MINIMAL DEFLATION. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043329 ↗
• MalfunctionJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 18440586 ↗
• MalfunctionOct 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BELOW THE KNEE ARTERY. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR ONE MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966834 ↗
• InjurySep 25, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 100% STENOSED, 150MMX3.0MM, TOTAL OCCLUDED TARGET LESION WITH NO SIGNIFICANT BEND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED COAXIALLY AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION. A TWO 3.0 MM X 150 150MM X 150CM COYOTE BALLOON CATHETERS WERE ADVANCED FOR DILATION IN AN UNKNOWN ORDER. WITH THE USED OF ENCORE 26 INFLATION DEVICE, THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES FOR 120 SECONDS AND CONTRAST MEDIA AND THE CONTRAST RATIO IN THE INFLATION DEVICE WAS 100%. HOWEVER, THE DEVICE WOULD NOT DEFLATE AT ALL. FURTHERMORE, DEEP-SEATING AND OVER-INFLATION AND NEGATIVE PRESSURE WITH LARGE SYRINGE THE BALLOON WAS RE-INFLATED, BUT THE BALLOON STILL WOULD NOT BE DEFLATED. HENCE, ADDITIONAL INTERVENTION WAS PERFORMED, AND THE DEVICE WAS REMOVED FROM THE PATIENT INTACT IN FULLY INFLATED STATE. NO PATIENT COMPLICATIONS NOR SERIOUS INJURIES WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT A 50/50 RATIO OF CONTRAST TO STERILE SALINE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813896 ↗
• InjurySep 25, 2023Leak/Splash; Failure to Deflate; Leak/Splash; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 100%, 140MM X 3MM, TOTAL OCCLUDED TARGET LESION WITH NO SIGNIFICANT BEND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. AFTER A 6F NON-BOSTON SCIENTIFIC GUIDE CATHETER WAS ENGAGED AND A NON-BSC GUIDE WIRE WAS CROSSED THE LESION, PRE DILATATION WAS PERFORMED. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES FOR 120 SECONDS USING ENCORE 26 INFLATION DEVICE WITH A CONTRAST RATIO OF 100%. HOWEVER, AFTER INFLATION, THE BALLOON FAILED TO DEFLATE. ADDITIONALLY, A DEEP-SEATING AND OVER-INFLATION, NEGATIVE PRESSURE WITH LARGE SYRINGE, THE BALLOON WAS RE-INFLATED, STILL THE BALLOON FAILED TO BE DEFLATED. THE BALLOON WAS TORN WHEN PULLING AND WAS REMOVED INTACT FULLY DEFLATED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT A 50/50 RATIO OF CONTRAST TO STERILE SALINE WAS USED, NOT 100% CONTRAST AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807830 ↗
• InjurySep 25, 2023Leak/Splash; Failure to Deflate; Leak/Splash; Failure to Deflate

  IT WAS REPORTED THAT A BALLOON DEFLATION ISSUE OCCURRED. THE PATIENT WAS UNDERGOING PERIPHERAL ANGIOPLASTY IN A MILDLY TORTUOUS VESSEL BELOW THE KNEE. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 140MM X 3.0MM TARGET LESION WAS 100% STENOSED AND MODERATELY CALCIFIED. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES FOR 120 SECONDS. THE CONTRAST RATIO WAS 100%. DURING DEFLATION, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN ATTEMPTED DIFFERENT TECHNIQUES TO DEFLATE THE BALLOON, WITHOUT SUCCESS. THE BALLOON TORE WHEN PULLING AND WAS THEREFORE REMOVED FULLY DEFLATED. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT A 50/50 RATIO OF CONTRAST TO STERILE SALINE WAS USED, NOT 100% CONTRAST AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807379 ↗
• InjurySep 25, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A BALLOON DEFLATION ISSUE OCCURRED. THE PATIENT WAS UNDERGOING PERIPHERAL ANGIOPLASTY IN A MILDLY TORTUOUS VESSEL BELOW THE KNEE. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 140MM X 3.0MM TARGET LESION WAS 100% STENOSED AND MODERATELY CALCIFIED. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES FOR 120 SECONDS. THE CONTRAST RATIO WAS 100%. DURING DEFLATION, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN ATTEMPTED DIFFERENT TECHNIQUES TO DEFLATE THE BALLOON, WITHOUT SUCCESS. THE BALLOON WAS REMOVED FROM THE PATIENT INTACT BUT REMAINED FULLY INFLATED. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT A 50/50 RATIO OF CONTRAST TO STERILE SALINE WAS USED, NOT 100% CONTRAST AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807376 ↗
• InjurySep 25, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A BALLOON DEFLATION ISSUE OCCURRED. THE PATIENT WAS UNDERGOING PERIPHERAL ANGIOPLASTY IN A MILDLY TORTUOUS VESSEL BELOW THE KNEE. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 150MM X 3.0MM TARGET LESION WAS 100% STENOSED AND MODERATELY CALCIFIED. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES FOR 120 SECONDS. THE CONTRAST RATIO WAS 100%. DURING DEFLATION, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN ATTEMPTED DIFFERENT TECHNIQUES TO DEFLATE THE BALLOON, WITHOUT SUCCESS. THE BALLOON WAS REMOVED FROM THE PATIENT INTACT AND REMAINED FULLY INFLATED. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT A 50/50 RATIO OF CONTRAST TO STERILE SALINE WAS USED, NOT 100% CONTRAST AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807375 ↗
• InjurySep 3, 2023Leak/Splash; Failure to Deflate; Leak/Splash; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 100% STENOSED, 140MMX3.0MM, TOTAL OCCLUDED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED COAXIALLY AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION. PRE-DILATION WAS PERFORMED, THEN A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. USING AN ENCORE 26 INFLATION DEVICE, THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES FOR 120 SECONDS. THE CONTRAST RATIO IN THE INFLATION DEVICE WAS 100%. THE BALLOON WOULD NOT DEFLATE DESPITE MULTIPLE ATTEMPTS AND TECHNIQUES. THE BALLOON TORE WHILE PULLING AND WAS THEN ABLE TO BE REMOVED FROM THE PATIENT INTACT AND FULLY DEFLATED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT A 50/50 RATIO OF CONTRAST TO STERILE SALINE WAS USED, NOT 100% CONTRAST AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675037 ↗
• InjurySep 1, 2023Leak/Splash; Failure to Deflate; Leak/Splash; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 100% STENOSED, 140MMX3.0MM, TOTAL OCCLUDED TARGET LESION WITH NO SIGNIFICANT BEND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED COAXIALLY AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. WITH THE USED OF ENCORE 26 INFLATION DEVICE, THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES FOR 120 SECONDS AND CONTRAST MEDIA AND THE CONTRAST RATIO IN THE INFLATION DEVICE WAS 100%. HOWEVER, THE DEVICE WOULD NOT DEFLATE DESPITE MULTIPLE ATTEMPTS AND TECHNIQUES. THE BALLOON TORE WHILE PULLING AND WAS THEN ABLE TO BE REMOVED FROM THE PATIENT INTACT AND FULLY DEFLATED. NO PATIENT COMPLICATIONS NOR SERIOUS INJURIES WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674640 ↗
• InjurySep 1, 2023Leak/Splash; Failure to Deflate; Leak/Splash; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 100%, 140MM X 3MM, TOTAL OCCLUDED TARGET LESION WITH NO SIGNIFICANT BEND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. AFTER A 6F NON-BOSTON SCIENTIFIC GUIDE CATHETER WAS ENGAGED AND A NON-BSC GUIDE WIRE WAS CROSSED THE LESION, PRE DILATATION WAS PERFORMED. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES FOR 120 SECONDS USING ENCORE 26 INFLATION DEVICE WITH A CONTRAST RATIO OF 100%. HOWEVER, AFTER INFLATION, THE BALLOON FAILED TO DEFLATE. ADDITIONALLY, A DEEP-SEATING AND OVER-INFLATION, NEGATIVE PRESSURE WITH LARGE SYRINGE, THE BALLOON WAS RE-INFLATED, STILL THE BALLOON FAILED TO BE DEFLATED. THE BALLOON WAS TORN WHEN PULLING AND WAS REMOVED INTACT FULLY DEFLATED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THIS BALLOON DID NOT TEAR DURING REMOVAL. IT WAS REMOVED FULLY INFLATED. IT WAS FURTHER REPORTED THAT A 50/50 RATIO OF CONTRAST TO STERILE SALI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674384 ↗
• InjurySep 1, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 100%, 140MM X 3MM, TOTAL OCCLUDED TARGET LESION WITH NO SIGNIFICANT BEND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. AFTER A 6F NON-BOSTON SCIENTIFIC GUIDE CATHETER WAS ENGAGED AND A NON-BSC GUIDE WIRE WAS CROSSED THE LESION, PRE DILATATION WAS PERFORMED. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES FOR 120 SECONDS USING ENCORE 26 INFLATION DEVICE WITH A CONTRAST RATIO OF 100%. HOWEVER, AFTER INFLATION, THE BALLOON FAILED TO DEFLATE. ADDITIONALLY, A DEEP-SEATING AND OVER-INFLATION, NEGATIVE PRESSURE WITH LARGE SYRINGE, THE BALLOON WAS RE-INFLATED, STILL THE BALLOON FAILED TO BE DEFLATED. THE DEVICE WAS REMOVED INTACT FULLY INFLATED, AND THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674045 ↗
• InjurySep 1, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 100% STENOSED, 150MMX3.0MM, TOTAL OCCLUDED TARGET LESION WITH NO SIGNIFICANT BEND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED COAXIALLY AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. WITH THE USED OF ENCORE 26 INFLATION DEVICE, THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES FOR 120 SECONDS AND CONTRAST MEDIA AND THE CONTRAST RATIO IN THE INFLATION DEVICE WAS 100%. HOWEVER, THE DEVICE WOULD NOT DEFLATE AT ALL. FURTHERMORE, DEEP-SEATING AND OVER-INFLATION AND NEGATIVE PRESSURE WITH LARGE SYRINGE THE BALLOON WAS RE-INFLATED, BUT THE BALLOON STILL WOULD NOT BE DEFLATED. HENCE, ADDITIONAL INTERVENTION WAS PERFORMED, AND THE DEVICE WAS REMOVED FROM THE PATIENT INTACT IN FULLY INFLATED STATE. NO PATIENT COMPLICATIONS NOR SERIOUS INJURIES WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673886 ↗
• MalfunctionMay 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TOTAL OCCLUDED OF 80%STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 7 ATMOSPHERES FOR LESS THAN 10 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED, AND NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. ANGIOPLASTY WAS DONE WITH ANOTHER SIZE OF THE DEVICE AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850873 ↗
• MalfunctionFeb 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN POPLITEAL ARTERY. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON COULD NOT BE FULLY DILATED. AFTER IT WAS WITHDRAWN, LIQUID WAS INJECTED BUT THE BALLOON WAS LEAKING, AND IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321914 ↗
• MalfunctionJul 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 3X150 COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047730 ↗
• MalfunctionMay 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS INSERTED AND A NON-BSC GUIDEWIRE CROSSED THE LESION, A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 10 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 CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518065 ↗
• MalfunctionNov 25, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18-NOV-2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. A 3.0MM X 150MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON LEAKED. IT WAS NOTED THAT NO PINHOLE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874326 ↗
• MalfunctionAug 10, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE 100% STENOSED, 3.0MM X 250 TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MULTI-FOCAL WITH MODERATELY CALCIFIED PROXIMAL TO MID ANTERIOR TIBIAL ARTERY. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS SUCCESSFULLY INFLATED AT 8 ATMOSPHERES FOR 30 SECONDS. HOWEVER, DURING REMOVAL, THERE WAS A SLIGHT ISSUE ON THE WIRE BUT WAS REMOVED SUCCESSFULLY. PROCEDURE CONTINUED WITH ATHERECTOMY AND WHEN TRIED TO POST DILATE WITH THE BALLOON, IT WAS NOTICED THAT THE WIRE LUMEN PORTION TWISTED AND KINKED. THE DEVICE WAS REMOVED OVER THE WIRE AND A NEW 2.5X150X150 COYOTE BALLOON CATHETER WAS OPENED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302043 ↗