Coyote™ H74939186252210Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08714729796718), received between Aug 30, 2018 and May 27, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT HUB LEAK WAS NOTED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN THE BALLOON WAS INFLATED TO THE NOMINAL PRESSURE, THE BALLOON WAS LEAKING AT THE HUB. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A HOLE AND KINK 7.5CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300406 ↗
• MalfunctionApr 2, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762194 ↗
• MalfunctionAug 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 2.5MM X 220MM X 150CM COYOTE OTW BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 14 ATMOSPHERES FOR 2 MINUTES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X220 COYOTE BALLOON CATHETER. NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887273 ↗
• MalfunctionJul 28, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURIG INFLATION, IT WAS NOTED THAT THE BALLOON BURST, AND THE CONTRAST MEDIUM WAS LEAKING. 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 22636760 ↗
• MalfunctionMay 21, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01MAY2025. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT FULLY EXPAND. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE 36MM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060055 ↗
• MalfunctionMar 20, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT BALLOON FROZE ON WIRE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 2.5MM X 220MM X 150CM, COYOTE BALLOON CATHETER WAS SELECTED FOR USE IN A BELOW THE KNEE ANGIOPLASTY. DURING PROCEDURE, THE BALLOON WAS INFLATED AT 8 ATMOSPHERE FOR 2 MINUTES. THE BALLOON WAS FULLY DEFLATED AND WAS DIRECTLY REMOVED. HOWEVER, IT WAS NOTED THAT THE BALLOON INSIDE THE LUMEN BECAME STUCK TO THE WIRE AND WAS DIFFICULT TO BE REMOVED. THE BALLOON ALONG WITH THE WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652857 ↗
• MalfunctionMar 12, 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 LEFT BELOW-KNEE VESSEL. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584597 ↗
• MalfunctionAug 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL OF BELOW THE KNEE. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 50% STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953521 ↗
• MalfunctionJan 25, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON AND A 300 CM, 18G VICTORY 14 GUIDEWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER AN UNSUCCESSFUL ATTEMPT TO ACCESS THE TARGET LESION FROM THE POPLITEAL ARTERY, THE VICTORY GUIDEWIRE WAS TAKEN OUT OF THE BALLOON TO INSERT ANOTHER WIRE. HOWEVER, THE TIP OF THE WIRE BECAME DETACHED AND GOT STUCK IN THE HUB. TO DISLODGE THE STUCK TIP, A SALINE SOLUTION WAS INJECTED INTO THE BALLOON AND THE BACK END OF THE VICTORY GUIDEWIRE WAS USED TO PUSH OUT THE DETACHED TIP IN THE BALLOON HUB OUTSIDE OF THE PATIENT. HENCE, THE TIP OF THE BALLOON WAS NOTICED TO BE KINKED DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT VICTORY GUIDEWIRE AND A DIFFERENT COYOTE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584684 ↗
• MalfunctionDec 6, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO DEFLATE. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY BELOW THE KNEE. A 2.5MM X 220MM X 150CM COYOTE WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS UNABLE TO DEFLATE. THE BALLOON WAS SIMPLY PULLED OUT CAREFULLY AND SLOWLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278932 ↗
• InjuryJul 19, 2023Material Separation; Use of Device Problem; Difficult to Advance; Material Separation; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED THAT THE BALLOON PROTECTOR DISLODGED INSIDE THE PATIENT. A COYOTE BALLOON WAS SELECTED FOR USE IN THE TIBIOPERONEAL TRUNK TO TREAT STENOSIS. THE COYOTE BALLOON WAS PASSED TO THE TIBIOPERONEAL TRUNK. HOWEVER, THERE WAS DIFFICULTY ADVANCING THE BALLOON ANY FURTHER. THE BALLOON WAS ATTEMPTED TO BE ADVANCED SEVERAL TIMES BY RETRACTING THE BALLOON CATHETER AND THEN ADVANCING FORWARD. THE BALLOON THOUGH, WOULD NOT ADVANCE FURTHER. IT WAS DECIDED TO EXCHANGE THE BALLOON FOR A SMALLER COYOTE BALLOON. THE NEW BALLOON WAS PREPPED. ON FLUORO, AN ARTIFACT WAS OBSERVED. THE SECOND COYOTE BALLOON WAS ADVANCED OVER THE GUIDEWIRE TO THE TIBIAL PERONEAL TRUNK. AT THE SAME LOCATION, THERE WAS ALSO DIFFICULTY ADVANCING THIS BALLOON. DESPITE SEVERAL ATTEMPTS, IT COULD NOT ADVANCE. THE GUIDEWIRE AND BALLOON CATHETER WERE REMOVED TOGETHER. IT WAS THEN DECIDED TO IVUS THE AREA TO DETERMINE IF SOMETHING WAS LEFT INSIDE THE PATIENT. A SURGEON WAS CALLED IT TO REMOVE IT. IVUS FOUND NOTHING, AND THE SURGEON WOULD NOT OPEN UP THE ARTERY WITHOUT CONFIRMATION OF A DETACHED COMPONENT. IT WAS THOUGHT THAT THE SECOND BALLOON WAS ADVANCED INTO THE DISLODGED BALLOON PROTECTOR. THE BALLOON WAS THEN JA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351827 ↗
• MalfunctionAug 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE OCCLUDED STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255078 ↗
• MalfunctionJul 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA IPSILATERAL ANTEGRADE APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY. AFTER A GUIDEWIRE CROSSED THE LESION, A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FOURTH INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH DILATATION OF A 3-200 AND 3MM NON BOSTON SCIENTIFIC DEVICES. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15049237 ↗
• MalfunctionJun 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING IPSILATERAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT POSTERIOR TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES . HOWEVER, DURING THE SECOND INFLATION AT 14 ATMOSPHERES , THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES NOR COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712089 ↗
• MalfunctionMay 16, 2022Entrapment of Device; Difficult to Advance; Material Twisted/Bent; Entrapment of Device; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED ON THE GUIDEWIRE. THE SEVERELY CALCIFIED AND MILDLY TORTUOUS TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR USE IN THE PROCEDURE; HOWEVER, WHEN ADVANCING THE CATHETER, IT WAS UNABLE TO ADVANCE OVER THE .014 INCH THRUWAY GUIDEWIRE. THEY ATTEMPTED TO RE-PRIME AND REX THE CATHETER BUT WERE UNSUCCESSFUL. THEY REPLACED THE THRUWAY GUIDEWIRE AND CONTINUED TO HAVE DIFFICULTY ADVANCING THE JETSTREAM, SO THE JETSTREAM XC CATHETER WAS REMOVED. DAMAGE TO THE CATHETER WAS NOTED AND THE GUIDEWIRE HAD KINKED IN MULTIPLE LOCATIONS, SO THE JETSTREAM XC CATHETER WAS REPLACED WITH THE 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER IN AN ATTEMPT TO GAIN FURTHER ACCESS INTO THE VESSEL. THE COYOTE BALLOON CATHETER WOULD NOT ADVANCE OVER THE THRUWAY GUIDEWIRE EITHER, SO THE BALLOON WAS REMOVED. WHEN THE BALLOON WAS REMOVED, IT APPEARED TWISTED AROUND THE WIRE, SO BOTH THE COYOTE BALLOON CATHETER AND THE THRUWAY GUIDEWIRE WERE REMOVED TOGETHER. ANOTHER THRUWAY GUIDEWIRE AND ANOTHER JETSTREAM CATHETER WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14411891 ↗
• MalfunctionFeb 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND 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 13552410 ↗
• MalfunctionNov 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BELOW-THE-KNEE VESSEL. A 2.5MM X 220MM 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 A PINHOLE WAS NOTED APPROXIMATELY 5CM FROM THE TIP OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12876203 ↗
• MalfunctionNov 24, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18-NOV-2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, EVIDENCE OF CONTRAST LEAKING OUT OF THE BALLOON WAS NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868435 ↗
• MalfunctionOct 28, 2021Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED BELOW-THE-KNEE VESSEL. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED OVER A 300CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE. HOWEVER, DURING INTRODUCTION, RESISTANCE WAS FELT AND IT WAS EVIDENT THAT THE BALLOON CATHETER HAD GOTTEN STUCK WITH THE GUIDEWIRE. FURTHERMORE, IT WAS NOTED THAT TIP OF THE GUIDEWIRE WAS KINKED. BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT AND THE LESION WAS RE-ACCESSED WITH NEW DEVICES. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711465 ↗
• MalfunctionOct 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 14 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. 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 12597517 ↗
• InjurySep 9, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 220MM X 150CM, COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION AND INFLATED AT 8 ATMOSPHERES FOR 120 SECONDS. HOWEVER, BALLOON WOULD NOT FULLY DEFLATE. THE PHYSICIAN ATTEMPTED MULTIPLE TIMES TO DEFLATE THE BALLOON AND USED THE DEFLATION DEVICE TO PULL NEGATIVE PRESSURE RESULTING TO ONLY MINIMAL DEFLATION OF THE BALLOON. ALSO, ATTEMPTED TO USE A 10CC SYRINGE WITH NEGATIVE PRESSURE BUT STILL THE BALLOON WOULD NOT FULLY DEFLATE THE RATIO WAS 40 CONTRAST AND 60 SALINE. SEVERAL ATTEMPTS WERE MADE OVER A COURSE OF A MINUTE. THE PHYSICIAN THEN PROCEEDED TO JUST REMOVE THE BALLOON WHILE STILL INFLATED. AND UPON REMOVING IT APPEARED TO BE DEFLATED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447129 ↗
• MalfunctionJul 21, 2021Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29JUN2021. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON DID NOT HOLD NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: Insufficient Information

  MAUDE report 12203260 ↗
• MalfunctionMar 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL BELOW THE RIGHT KNEE. AFTER A 4.5 NON-BOSTON SCIENTIFIC INTRODUCER SHEATH AND MICRO CATHETER WERE PLACED, AND A GUIDEWIRE CROSSED THE LESION, A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES (ATM). WHEN THE PRESSURE WAS INCREASED FROM 12ATM TO 14ATM ON THE SECOND DILATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED USING A 2.5X240 NON-BSC BALLOON CATHETER INFLATED AT ABOUT 18ATM. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11518545 ↗
• MalfunctionMar 16, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 2.5MM X 220MM X 150CM, OTW COYOTE BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, A NON-BSC GUIDEWIRE WAS STUCK ON THE BALLOON CATHETER. THE DEVICE WAS COMPLETELY REMOVED AS A WHOLE AND NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497073 ↗
• MalfunctionMar 8, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS STUCK ON THE WIRE. BOTH WIRE AND BALLOON CATHETER WERE REMOVED FROM THE PATIENT TOGETHER AT THE SAME TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436520 ↗