Gladiator™ Elite H74939207080470Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729809876), received between Mar 27, 2019 and Mar 10, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST AND ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT PRESENTED WITH POOR DIALYSIS BLOOD FLOW FOR APPROXIMATELY ONE MONTH. EXAMINATION IDENTIFIED VASCULAR STENOSIS OF THE ARTERIOVENOUS FISTULA AS THE CAUSE. TO IMPROVE DIALYSIS FLOW, AN 8 MM GLADIATOR BALLOON DILATATION CATHETER WAS SELECTED. SEVERAL DILATIONS WERE PERFORMED BEGINNING AT THE PROXIMAL STENOTIC REGION OF THE CEPHALIC VEIN USING 8 TO 20 ATMOSPHERES FOR APPROXIMATELY 60 SECONDS PER INFLATION. DURING DILATION OF THE FISTULA OPENING, APPROXIMATELY 20 ATMOSPHERES WAS APPLIED FOR ABOUT 40 SECONDS WHEN THE BALLOON SUDDENLY BURST. IMMEDIATE EXAMINATION CONFIRMED NO VESSEL RUPTURE OR ACTIVE BLEEDING. HOWEVER, THE BALLOON WAS DIFFICULT TO WITHDRAW AND WAS REPORTED TO HAVE COLLAPSED. HEMOSTASIS WAS ACHIEVED USING A TOURNIQUET. THE PUNCTURE SITE AND VESSEL WERE SURGICALLY OPENED TO REMOVE THE BALLOON, AND THE VESSEL WAS SUTURED. AFTER TOURNIQUET RELEASE, NO BLEEDING OR OOZING WAS OBSERVED. THE SKIN WAS SUBSEQUENTLY SUTURED, DISINFECTED WITH IODOPHOR, AND BANDAGED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561505 ↗
• MalfunctionJan 6, 2026Inflation Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17DEC2025. IT WAS REPORTED THAT BALLOON INFLATION ISSUE OCCURRED. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO THE RATED BURST PRESSURE (RBP). HOWEVER, THE BALLOON DID NOT FULLY EFFACE. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974298 ↗
• InjuryNov 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOTIC TARGET LESION WAS LOCATED IN THE LEFT UPPER EXTREMITY AND SUPERIOR VENA CAVA. AN 8.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS SELECTED FOR LEFT UPPER EXTREMITY VENOGRAPHY AND SUPERIOR VENA CAVOGRAPHY, ALONG WITH BALLOON ANGIOPLASTY FOR VENOUS STENOSIS OF THE ARTERIOVENOUS FISTULA. DURING THE PROCEDURE, WHEN THE RATED BURST PRESSURE WAS REACHED, THE BALLOON ACHIEVED ONLY 90% DILATION, INDICATING PERSISTENT STENOSIS. AFTER TWO ADDITIONAL INFLATIONS, THE BALLOON WAS DEFLATED, RESULTING IN REDUCED PRESSURE WITHIN THE FISTULA AND A PALPABLE THRILL AT THE ANASTOMOSIS. FOLLOW-UP ANGIOGRAPHY SHOWED A RESIDUAL LUMINAL DIAMETER OF APPROXIMATELY 6 MM AT THE STENOTIC SITE, SUGGESTING ELASTIC RECOIL. A THIRD DILATION WITH THE SAME BALLOON WAS THEREFORE ATTEMPTED. WHEN THE BALLOON PRESSURE REACHED 19 ATMOSPHERES, CONTRAST MEDIUM WAS SUDDENLY OBSERVED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) TO DIFFUSE FROM WITHIN THE BALLOON INTO THE VESSEL. THE PATIENT REMAINED ASYMPTOMATIC. BALLOON RUPTURE WAS SUSPECTED, AND THE BALLOON WAS IMMEDIATELY AND SLOWLY WITHDRAWN. UPON REMOVAL FROM THE SHEATH AND INSPECTION OUTSIDE THE BODY, A LONGITUDINA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649489 ↗
• MalfunctionOct 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING A FISTULOGRAM WITH ANGIOPLASTY PERFORMED TO ADDRESS PERSISTENT PAIN IN THE VASCULAR ACCESS, AN 8.0 X 40, 75 CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES WHILE ATTEMPTING TO REACH THE RATED BURST PRESSURE OF 20 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT COMPLICATION, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER GLADIATOR ELITE BALLOON CATHETER OF THE SAME SIZE. A POST-PROCEDURE ANGIOGRAM DEMONSTRATED IMPROVED CONTRAST FLOW THROUGH THE FISTULA. HEMOSTASIS WAS ACHIEVED, AND THE PATIENT WAS TRANSFERRED TO THE POSTOPERATIVE RECOVERY ROOM IN SATISFACTORY CONDITION. IT FURTHER REPORTED THAT THE 8.0 X 40 MM, 75 CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION AT THE EDGE OF AN INDWELLING NON-BOSTON SCIENTIFIC STENT GRAFT NEAR THE GRAFT-VEIN ANASTOMOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346379 ↗
• MalfunctionJun 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE BASILIC BRANCH OF REFLUXING VEIN OF LEFT UPPER LIMB. A GLADIATOR ELITE 8.0 X40, 75CM BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, UPON INFLATION, IT WAS OBSERVED THAT THE BALLOON HAD RUPTURED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212891 ↗
• MalfunctionMay 20, 2025Inflation Problem; Material Integrity Problem; Inflation Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON WAS DAMAGED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ARTIFICIAL ARTERIOVENOUS FISTULA OF THE LEFT UPPER LIMB. AN 8.0 X40, 75CM GLADIATOR? ELITE WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 18 ATMOSPHERES, THE PRESSURE WAS NOTED TO BE REDUCED. AFTER THE BALLOON WAS REMOVED, IT WAS FOUND TO BE DAMAGED. 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 22050551 ↗
• MalfunctionMar 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTIFICIAL ARTERIOVENOUS FISTULA IN LEFT UPPER LIMB ARTERY. A 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST EXPANSION AT 18 ATMOSPHERES, THE BALLOON BURST DESPITE THE PRESSURE BEING BELOW THE EXPECTED BURST PRESSURE. THE DEVICE WAS PULLED AND FOUND DAMAGED, AND THE PROCEDURE WAS COMPLETED BY INFLATING ANOTHER OF THE SAME MODEL. THE PATIENT CONDITION WAS WELL AND STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735052 ↗
• MalfunctionNov 23, 2024Inflation Problem; Material Integrity Problem; Inflation Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05NOV2024. IT WAS REPORTED THAT BALLOON DAMAGED OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED ARTIFICIAL ARTERIOVENOUS FISTULA IN THE LEFT UPPER LIMB. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED AT 18ATM ONCE; HOWEVER, THE PRESSURE WAS LESS THAN BURSTING PRESSURE, AND THE PRESSURE WAS FOUND TO BE REDUCED. THE BALLOON WAS PULLED OUT, AND IT WAS FOUND OUT THAT THE BALLOON WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766871 ↗
• MalfunctionAug 7, 2024Entrapment of Device; Difficult to Remove; Material Rupture; Entrapment of Device; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON BECAME STUCK, RUPTURED AND WAS DIFFICULT TO REMOVE FROM THE STENT. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, UPON GOING THROUGH A NEW STENT, THE BALLOON BECAME STUCK ON THE STIFF GLIDE. CONSEQUENTLY, THE BALLOON RIPPED AND WAS DIFFICULT TO REMOVE FROM THE STENT. THE DEVICE WAS REMOVED THROUGH THE SHEATH AND NO DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930162 ↗
• MalfunctionJul 8, 2024Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT FOREARM ARTERIOVENOUS FISTULA. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. ULTRASOUND CONFIRMED THAT THE BALLOON WAS PLACED IN A STENOSIS POSITION, AND AFTER THE PRESSURE PUMP WAS CONNECTED, THE HANDLE OF THE PRESSURE PUMP WAS ROTATED. HOWEVER, DURING SIXTH INFLATION AT 18 ATMOSPHERES FOR 30-60 SECONDS, THE PRESSURE DROPPED SHARPLY, AND THE ULTRASOUND SHOWED THAT THE BALLOON SHRANK AND WAS JUDGED THAT THE BALLOON RUPTURED. THE BALLOON WAS DIRECTLY REMOVED FROM THE VESSEL SHEATH AND FILLED IN VITRO, AND IT WAS FOUND THAT THE BALLOON WAS LACERATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19692040 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT BALLOON FRACTURED OCCURRED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE LEFT CEPHALIC VENOUS ARCH. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. UPON UNPACKING, IT WAS FOUND THAT THE CONNECTION BETWEEN THE BALLOON AND THE ADVANCER ROD WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908991 ↗
• MalfunctionDec 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS IN THE ARTERIOVENOUS INNER FISTULA. A 8.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80-90% STENOSED, MODERATELY TORTUOUS, AND SEVERELY CALCIFIED. THE BALLOON BURST AFTER BEING INFLATED SIX TO EIGHT TIMES AT 20 ATMOSPHERES FOR 50-60 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334825 ↗
• MalfunctionNov 3, 2023Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT BALLOON INFLATION FAILURE AND LOADING DIFFICULTIES ON WIRE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND NON-CALCIFIED ARCH OF CEPHALIC VEIN. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION, BUT THE BALLOON WAS DAMAGED AND COULD NOT INFLATE DESPITE APPLICATION OF PRESSURE AND THE GUIDEWIRE COULD NOT ENTER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18069980 ↗
• MalfunctionNov 3, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED, AND PARTIALLY SHEARED OFF THE SHAFT. FORTUNATELY, IT STAYED TO THE SHAFT BUT THERE WAS RESISTANCE COMING OUT OF THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED SOMEPLACE IN THE ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18069612 ↗
• MalfunctionSep 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE 70% STENOSED TARGET LESION WAS LOCATED IN THE UNKNOWN TORTUOSITY AND NON-CALCIFIED ARTERIOVENOUS FISTULA. THE DEVICE RUPTURED AT 24 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS RECOVERED TO THE SHEATH AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783239 ↗
• MalfunctionAug 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ARTERIOVENOUS FISTULA. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED FIVE TIMES AT 10 AND 20 ATMOSPHERES (ATM) RESPECTIVELY. HOWEVER, DURING SIXTH INFLATION AT 20 ATM, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED BY A CATHETER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628878 ↗
• MalfunctionJun 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CEPHALIC VEIN ARCH TO RIGHT SUBCLAVIAN VEIN. AN 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. WHEN THE BALLOON WAS INFLATED AT 4 ATMOSPHERES, THE PRESSURE WOULDN'T LONGER INCREASE, AND CONTRAST WAS FLOWING BACK TO THE HEART. DURING WITHDRAWAL OF THE DEVICE, THE BALLOON WAS FOUND TO BE RUPTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS WITH 90% STENOSIS. IT WAS NOTED THAT THE DURATION OF INFLATION WAS 30 SECONDS TO ONE MINUTE AND A PINHOLE WAS NOTED ON THE BALLOON. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232230 ↗
• MalfunctionApr 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN ARTERIOVENOUS ENDOVASCULAR FISTULA. A 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON WAS BROKEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE 80-90% STENOSED TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. IN ADDITION, THE BALLOON RUPTURED DURING THE SIXTH INFLATION AT 20 ATMOSPHERES FOR 50 SECONDS. THEN, THE DEVICE WAS REMOVED USING THE CATHETER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16760927 ↗
• MalfunctionFeb 21, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS BROKEN. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS BROKEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE STENOSED TARGET LESION WAS 80-85% LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. THE BALLOON MATERIAL BROKE AND WAS REMOVED WITH USED OF CATHETER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408628 ↗
• MalfunctionJul 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN VENOUS ANASTOMOSIS IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ARM. A 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON LEAK AT 10 ATMOSPHERES AND DURING SECOND INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE BALLOON WAS ASPIRATED AND REMOVED ALL THE BALLOON INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 8X40 GLADIATOR BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15037086 ↗
• MalfunctionApr 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VENOUS SIDE OF ARTERIOVENOUS DIALYSIS GRAFT. AN 8.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. 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 14002134 ↗
• MalfunctionFeb 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY. A 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE PRESSURE WENT DOWN AND BLOOD WAS NOTED IN THE INFLATION TUBING. THE DEVICE WAS PULLED OUT FROM THE PATIENT INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 8.0X60, 75CM GLADIATOR BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450557 ↗
• MalfunctionMay 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 40% STENOSED TARGET LESION WAS LOCATED IN THE ARM. A 8.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING THIRD INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824846 ↗
• MalfunctionOct 11, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE/PERFORATED OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ARM. A 12.0X40MM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AS THE BALLOON WAS PULLED NEGATIVE, BACKFLOW OF BLOOD IN THE INFLATION SYRINGE WAS NOTED DUE TO A PINHOLE SOMEWHERE IN THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9180180 ↗
• InjuryOct 3, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A LEFT ARTERIOVENOUS FISTULA. A 7.0 X 40, 75 CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REPLACED WITH ANOTHER 8.0 X 40, 75 CM GLADIATOR ELITE BALLOON CATHETER; HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED AND THE BALLOON PARTS CAME OFF. THE BROKEN FRAGMENTS WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Code Available

  MAUDE report 9152998 ↗