Coyote™ ES H74939134204010Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 08714729767350), received between Sep 18, 2018 and Apr 23, 2026 — classified as 3 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (90 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 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Material 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 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT14 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 A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965063 ↗
• MalfunctionApr 20, 2026Material 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 2MM X 40MM X 144CM COYOTE ES BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, 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 24923382 ↗
• MalfunctionApr 13, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL OF BELOW THE KNEE. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 20 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 24858745 ↗
• MalfunctionApr 2, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS 95 -100% STENOSED, MODERATELY TORTUOUS AND SEVERELY CALCIFIED. A 2MM X 40MM X 144CM COYOTE ES WAS USED IN THE DISTAL TIBIAL ARTERY, A 4MM X 40MM X 145CM COYOTE ES WAS USED IN THE TIBIOPERONEAL ARTERY AND A 2.5X60X150 STERLING WAS USED IN THE MID TIBIAL ARTERY. DURING THE FIRST INFLATION AT 10 - 12 ATMOSPHERES FOR LESS THAN 20 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED OVER THE WIRE THROUGH THE SHEATH, 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 24767279 ↗
• MalfunctionMar 30, 2026Material 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 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 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 24726685 ↗
• MalfunctionMar 8, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUPERFICIAL ARTERY. AFTER CROSSING THE LESION WITH A GUIDEWIRE, A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE SECOND INFLATION AT 14 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 A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541719 ↗
• MalfunctionFeb 15, 2026Material 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 2MM X 40MM X 144CM COYOTE ES BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 30 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 24341644 ↗
• MalfunctionDec 29, 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 2MM X 40MM X 144CM COYOTE OTW BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 8 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION WERE GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905263 ↗
• MalfunctionDec 16, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. THE TARGET LESION WAS LOCATED IN THE VERY DISTAL RIGHT ANTERIOR TIBIAL ARTERY. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS SELECTED FOR ANGIOGRAM WITH INTERVENTION. HOWEVER, IT WAS NOTED THAT THE BALLOON SHOWED A DARK CONTRAST WHEN INFLATED AND HAD DIFFICULTY DEFLATING. MULTIPLE ATTEMPTS WERE MADE TO BURP THE IN DEFLATOR AND USING A 3CC SYRINGE TO ADD ADDITIONAL PRESSURE TO DECOMPRESS THE BALLOON. AFTER SEVERAL ATTEMPTS FOR 5-7 MINUTES. THE BALLOON FINALLY DEFLATED AFTER MANUALLY MILKING IT. ANGIOGRAM REVEALED NO DAMAGE TO VESSEL AND POSITIVE RESULTS FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT FULLY RECOVERED POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818517 ↗
• MalfunctionNov 25, 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 ILIAC VEIN. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SECOND INFLATION AT 7 ATMOSPHERES FOR 7 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 23649919 ↗
• MalfunctionAug 12, 2025Material 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 2MM X 40MM X 144CM COYOTE OTW BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH HIGHLANDER BALLOON CATHETER OF THE SAME DIAMETER. NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783279 ↗
• MalfunctionJul 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 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 22553134 ↗
• MalfunctionMay 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MILD CALCIFIED VESSEL BELOW THE KNEE. A 2MM X 40MM X 144CM COYOTE ES 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 22097260 ↗
• InjuryMar 18, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON RUPTURED AND SEPARATED INSIDE THE PATIENT, REQUIRING A SNARE FOR REMOVAL. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY (PA). A 2MM X 40MM X 144CM COYOTE ES WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, UPON INFLATING THE DEVICE, THE BALLOON RUPTURED. UPON REMOVAL, THE BALLOON GOT CAUGHT ON THE NODULE AND WAS SEPARATED INSIDE THE PATIENT. ALL OF THE SEPARATED PARTS WERE ABLE TO BE RETRIEVED WITH A SNARE, SO NO FRAGMENTS REMAINED INSIDE THE PATIENT. 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 21632903 ↗
• MalfunctionMar 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2MM X 40MM X 144CM COYOTE ES WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584403 ↗
• MalfunctionFeb 18, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05FEB2025. IT WAS REPORTED THAT INFLATION ISSUE OCCURRED. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT THE LESION, IT WAS NOTED THAT THE BALLOON SLOWLY DEFLATING. BALLOON WAS ATTEMPTED TO REINFLATE MULTIPLE TIMES. THE BALLOON WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A HOLE IN THE GUIDEWIRE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394285 ↗
• MalfunctionFeb 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS VIA CONTRALATERAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING SECOND INFLATION AT APPROXIMATELY 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM. A NEW 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS USED FOR FURTHER DILATION, HOWEVER, UPON THIRD INFLATION AT APPROXIMATELY 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON ALSO RUPTURED IN A PINHOLE FORM. BOTH DEVICES WERE REMOVED USING NORMAL METHOD WITHOUT ISSUE, 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 21294727 ↗
• MalfunctionDec 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LOWER EXTREMITY ARTERY. A 2MM X 40MM X 144CM COYOTE ES BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, IT WAS NOTED THAT THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035614 ↗
• MalfunctionNov 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2MM X 40MM X 144CM COYOTE ES WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 5 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM AT NEAR THE BALLOON SHOULDER. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650804 ↗
• MalfunctionSep 19, 2024Material 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 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, 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 20263205 ↗
• MalfunctionAug 26, 2024Material 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 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION UNTIL IT REACHED THE 10 ATMOSPHERES. 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 20071807 ↗
• MalfunctionMay 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND LEAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE SECOND INFLATION, AT 8 ATMOSPHERES THERE WAS A LEAK NOTED, AND IN THE SAME ATMOSPHERIC PRESSURE FOR ABOUT 10 SECONDS, THE BALLOON RUPTURED. IN ADDITION, IT WAS CONFIRMED THAT THE DEVICE WAS NOT USED TO POST-DILATE A PREVIOUSLY PLACED STENT. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH NO FRAGMENTS LEFT INSIDE AND WAS REPLACED FOR A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274343 ↗
• MalfunctionMay 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED BELOW THE KNEE AND WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM WITH NO DAMAGE OBSERVED. THE POSITION OF THE RUPTURE WAS FOUND ON THE DISTAL TIP SLIGHTLY PROXIMAL AND A VERTICAL SHAPE. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247076 ↗
• MalfunctionApr 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION IS LOCATED BELOW THE KNEE AND IS MILDLY TORTUOUS AND MODERATELY CALCIFIED. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 8 ATMOSPHERES DURING THE INFLATION PERIOD. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND WAS REPLACED FOR A DIFFERENT PRODUCT TO COMPLETE THE PROCEDURE. THE DEVICE WAS NOT RETURNED AS IT WAS CONTAMINATED. THERE WERE NO COMPLICATIONS REPORTED, AND PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055823 ↗
• MalfunctionFeb 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL BELOW THE KNEE. A 2MM X 40MM X 144CM COYOTE ES BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784543 ↗