Coyote™ ES H74939135252010Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 08714729767206), received between Oct 11, 2018 and Dec 5, 2025 — classified as 3 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (60 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 64 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE GOT SEPARATED INSIDE THE CATHETER, REQUIRING SNARE FOR REMOVAL. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS SELECTED FOR ENDOVASCULAR TREATMENT. HOWEVER, UPON REMOVAL, THE DEVICE WAS TRAPPED IN THE CALCIFIED LESION AND RUPTURED. AFTER ADVANCING THE GUIDING SHEATH AND PULLING IT AGAIN, THE BALLOON PORTION BECAME SEPARATED INSIDE THE CATHETER. THE FRAGMENT WAS REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728379 ↗
• MalfunctionNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 6 ATMOSPHERES FOR 3SECONDS. A PINHOLE WAS LOCATED NEAR THE CENTER OF THE BALLOON. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607921 ↗
• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE ES MR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT THE NOMINAL BURST PRESSURE (NBP). 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 23012034 ↗
• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED BELOW THE KNEE. A 2.5MM X 20MM X 144CM COYOTE ES MR 2 BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002475 ↗
• MalfunctionAug 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL BELOW THE KNEE. A 2.5MM X 20MM X 144CM COYOTE ES MR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND 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 22750475 ↗
• InjuryJun 26, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT WAS DETACHED, REQUIRING INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE WIRE PASSED THROUGH THE LESION AND WAS WIDENED WITH A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER. SUBSEQUENTLY, THE SHAFT WAS MOVED TO ANOTHER LESION FOR PLAIN OLD BALLOON ANGIOPLASTY, BUT THERE WAS RESISTANCE ENCOUNTERED. FURTHER INFLATION AND DEFLATION WAS PERFORMED, AND THE SHAFT WAS PULLED. UPON PULLING THE SHAFT, IT WAS CONFIRMED THAT IT WAS DETACHED. A SNARE WAS USED TO RETRIEVE THE DETACHED PART, AND NO FOREIGN OBJECTS WERE LEFT IN THE BODY. 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 22338978 ↗
• MalfunctionMay 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE BELOW-KNEE VESSEL. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118289 ↗
• MalfunctionApr 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 12 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 AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871543 ↗
• MalfunctionMar 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION OF A NON-STENOSED TARGET LESION. HOWEVER, DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, 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 21643458 ↗
• MalfunctionJan 23, 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 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223765 ↗
• MalfunctionSep 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 10 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235586 ↗
• MalfunctionJul 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 19770597 ↗
• MalfunctionJul 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED BELOW THE KNEE VESSEL. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731537 ↗
• MalfunctionMay 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED OCCURRED. A 2.5MM X 20MM X 144CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 30SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264852 ↗
• MalfunctionFeb 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON SECOND INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 18784701 ↗
• MalfunctionFeb 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776420 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM AT THE MIDDLE PART. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528131 ↗
• MalfunctionDec 14, 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 VESSEL IN ILIAC ARTERY. A 12.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 20 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 18326964 ↗
• MalfunctionNov 13, 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 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SIXTH INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118970 ↗
• MalfunctionOct 26, 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 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010705 ↗
• MalfunctionOct 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 6 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 17971881 ↗
• MalfunctionSep 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED VERTICALLY. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME 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 17843187 ↗
• MalfunctionApr 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED SEVERE LIMB ISCHEMIA. THE 95% STENOSED TARGET LESION WAS LOCATED ON THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES FOR 2 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 CONDITION WAS IN GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728080 ↗
• MalfunctionJan 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION BELOW THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196452 ↗
• MalfunctionDec 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15897477 ↗