Coyote™ H74939186202210Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08714729796466), received between Aug 20, 2018 and Apr 15, 2026 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR SEVERAL SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885635 ↗
• InjuryDec 4, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED VIA FACILITY MEDWATCH#: (B)(4) THAT OCCLUSION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH REOCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) POPLITEAL AND ANTERIOR TIBIAL ARTERY ONE MONTH FOLLOWING A PREVIOUS ATHERECTOMY PROCEDURE. A 2.0MM X 220MM X 150CM COYOTE WAS USED IN THE ATHERECTOMY PROCEDURE. THE PATIENT WENT FOR A FOLLOW UP APPOINTMENT DUE TO LEG PAIN FOR TWO DAYS. THE PATIENT VISITED THE EMERGENCY DEPARTMENT, WHERE A VASCULAR ULTRASOUND SHOWED REOCCLUSION OF THE LEFT COMMON FEMORAL ARTERY (CFA) AND A POTENTIAL FOREIGN BODY IN THE RIGHT SFA EXTENDING FROM THE MID SFA TO THE PROXIMAL POPLITEAL ARTERY. THE PATIENT UNDERWENT A REPEAT LOWER EXTREMITY ANGIOGRAM THE NEXT DAY, FOLLOWED BY THROMBECTOMY AND ANGIOPLASTY OF THE LEFT SFA AND TIBIAL ARTERIES. THE FOREIGN BODY WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE RETAINED FOREIGN OBJECT MATCHED WITH THE OUTER COVERING OF ONE OF THE BALLOONS USED DURING THE INITIAL ANGIOGRAM. THE OBJECT WAS NOT NOTICED ON FLUOROSCOPY DURING THE INITIAL PROCEDURE DUE TO ITS TRANSPARENT, RADIOLUCENT NATURE. NO ADVERSE OUTCOMES OCCURRED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 20841779 ↗
• InjuryNov 5, 2024

  THE PREVIOUS ATHERECTOMY WAS PERFORMED ONE MONTH PRIOR TO THIS EVENT. NOW, THE PATIENT PRESENTED WITH A REOCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) POPLITEAL AND ANTERIOR TIBIAL ARTERY. PATIENT WENT FOR A FOLLOW UP APPOINTMENT DUE TO LEG PAIN FOR TWO DAYS. PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER AN EVALUATION AT CLINIC WITH VASCULAR ULTRASOUND SHOWING REOCCLUSION OF THE LEFT COMMON FEMORAL ARTERY (CFA) AND A POSSIBLE FOREIGN BODY IN THE RIGHT SFA EXTENDING FROM THE MID SFA TO THE PROXIMAL POPLITEAL ARTERY. PATIENT UNDERWENT REPEAT LOWER EXTREMITY ANGIOGRAM THE NEXT DAY, THEN PATIENT UNDERWENT THROMBECTOMY OF THE LEFT SFA ANGIOPLASTY AND TIBIAL ARTERIES AND SUCCESSFUL RETRIEVAL OF THE FOREIGN BODY. THE PRELIMINARY REPORT FROM INTERVENTIONAL RADIOLOGY INDICATED THAT THE RETAINED FOREIGN OBJECT (RFO) WAS NOT A REGULAR CATHETER THEY USE FOR ANGIOGRAM; IT APPEARED TO MATCH WITH THE OUTER COVERING OF ONE OF THE BALLOONS USED DURING THE FIRST ANGIOGRAM. IT IS NOT RADIOPAQUE, SO IT WAS NOT NOTICED ON FLOUROSCOPY. THE PLASTIC COVER IS TRANSPARENT AND RADIOLUCENT, SO BY DESIGN THAT MAKES IT A LITTLE DIFFICULT TO VISUALIZE. ALSO, USUALLY THE LIGHTS ARE DIMMED DURING A

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Pain

  MAUDE report 20608986 ↗
• MalfunctionApr 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.0MM X 220MM X 150CM COYOTE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094791 ↗
• MalfunctionAug 31, 2023Break; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem; Break; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON DETACHMENT OCCURRED. A 2.0MM X 220MM X 150CM, OTW COYOTE BALLOON DILATATION CATHETER WAS ADVANCED. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE, AND KINKS WERE ALSO NOTED IN THE MULTIPLE AREAS OF THE DEVICE. NO PATIENT HARM RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666555 ↗
• MalfunctionAug 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE. A 2.0MM X 220MM X 150CM, OTW COYOTE BALLOON DILATATION CATHETER WAS ADVANCED; HOWEVER, DURING THE PROCEDURE THE BALLOON WAS DAMAGED, AND RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT HARM RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637526 ↗
• MalfunctionJan 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 12 ATMOSPHERES FOR 40 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 WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270942 ↗
• MalfunctionSep 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A RUPTURE OCCURRED. A 2.0MM X 220MM X 150CM COYOTE AND A 4.0MM X 150MM X 150CM COYOTE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICES RUPTURED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486538 ↗
• MalfunctionMay 4, 2022Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. FOLLOWING ATHERECTOMY AND PRE-DILATATION, RESIDUAL STENOSIS WAS 30-40%. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE DEVICE WAS INFLATED AT NOMINAL PRESSURE AND WAS DEFLATED WITHOUT ISSUE. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS DIFFICULT TO REMOVE BUT EVENTUALLY REMOVED WITHOUT ISSUE. THE COYOTE BALLOON CATHETER WAS RE-INTRODUCED BUT IT WOULD NOT EVEN LOAD ON THE WIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282572 ↗
• MalfunctionMar 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BELOW THE KNEE. A 2.0MM X 220MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED ABOUT 5 CM AT THE TIP OF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665187 ↗
• MalfunctionDec 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 2.0MM X 220MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12958992 ↗
• MalfunctionJun 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 5 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048323 ↗
• MalfunctionFeb 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND HE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340903 ↗
• MalfunctionJan 5, 2021Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND DEVICE ENTRAPMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED AND THE DEVICE GOT STUCK WITH THE NON-BOSTON SCIENTIFIC GUIDEWIRE. BOTH DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11118566 ↗
• MalfunctionAug 28, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT AND BALLOON RUPTURE WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER AND A BX5 PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR THE PROCEDURE. DURING THE PROCEDURE, THE BALLOON COULD NOT BE PULLED BACK OVER THE WIRE AND BOTH WERE REMOVED FROM THE PATIENT'S BODY TOGETHER. THE WIRE WAS STUCK IN THE BALLOON. A NEW BALLOON AND WIRE WERE OPENED TO COMPLETE THE PROCEDURE. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467352 ↗
• MalfunctionJul 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10221834 ↗
• MalfunctionJun 25, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED AND WAS INFLATED AT 8 ATMOSPHERES FOR 30 SECONDS. HOWEVER, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE. AFTER NUMEROUS NEGATIVES PULLED WITH ENCORE 26 INFLATION DEVICE AND A 10CC SYRINGES, THE BALLOON DEFLATED AND WAS COMPLETELY REMOVED FROM THE BODY INTACT. IT TAKES AN EXTRA MINUTE TO REMOVE THE BALLOON FROM THE PATIENT DUE TO MULTIPLE NEGATIVES BEING PULLED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER COYOTE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10198197 ↗
• MalfunctionMay 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2.0MM X 220MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND 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 COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102137 ↗
• MalfunctionMay 28, 2020Material 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 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, 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 Consequences Or Impact To Patient

  MAUDE report 10099361 ↗
• MalfunctionApr 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9983637 ↗
• MalfunctionApr 15, 2020Material 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 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9961482 ↗
• MalfunctionFeb 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED BY PULLING NEGATIVE PRESSURE AND WITHDREW NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9703406 ↗
• MalfunctionFeb 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL POSTERIOR TIBIAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS INSERTED BUT THE WIRE PROLAPSED OUTSIDE THE TIP OF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9679184 ↗
• MalfunctionDec 2, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ANTERIOR TIBIAL VESSEL ON THE RIGHT LEG. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE WIRE STUCK IN THE LUMEN AND THE BALLOON STARTED TO TECHNICALLY ALMOST LIKE ACCORDION IN THE BODY. THE BALLOON AND WIRE WERE PULLED OUT. THE WIRE HAS BEEN REPLACED AND COMPLETED THE PROCEDURE WITH A DIFFERENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9396548 ↗
• MalfunctionOct 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 2.0MMX30MMX143CM COYOTE NC (NC QUANTUM APEX) BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. SUBSEQUENTLY, A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS USED. HOWEVER, DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON ALSO RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202426 ↗