Gladiator™ Elite H74939207050470Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729809678), received between Oct 8, 2018 and Feb 6, 2026 — classified as 4 injuries, 29 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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 24283563 ↗
• MalfunctionDec 29, 2025Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10DEC2025. IT WAS REPORTED THAT A BALLOON LEAK OCCURRED. A 5.0 X 40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE BALLOON WAS INFLATED ONCE TO A PRESSURE OF 12 ATM; HOWEVER, BEFORE REACHING THE TARGET PRESSURE, THE BALLOON BEGAN LEAKING LIQUID, WITH THE LEAK OCCURRING AT 10 ATM. THE TARGET VESSEL EXHIBITED A SIMPLE CURVATURE. UPON WITHDRAWAL OF THE DEVICE AND FURTHER PRESSURIZATION, THE BALLOON WAS OBSERVED TO CONTINUE LEAKING LIQUID. THE PATIENTS ANATOMICAL CONDITION WAS NOT PROVIDED, BUT NO SERIOUS INJURY OR ADVERSE EFFECTS WERE REPORTED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907853 ↗
• MalfunctionDec 4, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT BALLOON AIR LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED FISTULA. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS NOT HOLDING PRESSURE PROPERLY AND WAS LOSING AIR. THE LEAK WAS NOTICED AT THE HUB OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE LEAKAGE OCCURRED DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 2 MINUTES. THERE WAS NO PHYSICAL DAMAGE WAS NOTED TO THE DEVICE, AND THE LEAKAGE WAS NOTICED ONCE THE PRESSURE STARTED TO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714307 ↗
• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION, EXHIBITING 90% OR GREATER STENOSIS, WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS FISTULA. A 5.0 X 40 MM, 75 CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566793 ↗
• MalfunctionNov 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT A PRESSURE OF 20 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION IS 40% STENOSED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED. THE DEVICE WAS INFLATED TWICE AND RUPTURE AT 12 ATMOSPHERES FOR 10 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536061 ↗
• MalfunctionNov 3, 2025Inflation Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT INFLATION FAILURE AND LEAKAGE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS FOREARM, UPPER LIMB VESSEL. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE BALLOON FAILED TO INFLATE AT A PRESSURE OF 16 ATMOSPHERES. AFTER WITHDRAWING THE BALLOON FROM THE BODY AND REAPPLYING PRESSURE, A LIQUID LEAK WAS DETECTED. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE LOCATED APPROXIMATELY 22MM DISTAL FROM THE PROXIMAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447536 ↗
• MalfunctionJul 21, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE ARM. A 5.0 X 40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 20 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 22553126 ↗
• MalfunctionJun 23, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ARTERIES AND VEINS OF THE LEFT FOREARM. A 5.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. 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 22310507 ↗
• MalfunctionJun 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ANASTOMOTIC STOMA. A 5.0 X 40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST UPON FIRST INFLATION AT 2 ATMOSPHERES FOR 2 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150951 ↗
• MalfunctionApr 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ANASTOMOTIC STOMA. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 13 ATMOSPHERES IN LESS THAN 5 SECONDS, THE BALLOON BURST. THE DEVICE REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773542 ↗
• MalfunctionMar 25, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE ARTERIOVENOUS FISTULA POORLY FUNCTIONED, AND THE MOST STENOSED PART OF THE CEPHALIC VEIN WAS 1.3MM. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED TO THE LESION ALONG WITH THE GUIDEWIRE. THE PRESSURE PUMP WAS CONNECTED, AND THE BALLOON WAS PRESSURIZED TO 20 ATMOSPHERES AND DILATION WAS SMOOTH AND COMPLETED. SUBSEQUENTLY, THE NEGATIVE PRESSURE WAS PULLED, AND THE POSITION OF THE BALLOON WAS ADJUSTED. THE PHYSICIAN CONTINUED THE DILATION TO 22 ATMOSPHERES, BUT WHEN THE PRESSURE WAS MAINTAINED FOR ABOUT 15 SECONDS DURING THE INITIAL INFLATION, IT RAPIDLY DECREASED, AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT BY PULLING IT OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 75% STENOSED AND WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690000 ↗
• MalfunctionJan 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM VESSEL. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS PRESSURIZED TO 17 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 75% STENOSED, NON-TORTUOUS, AND NON-CALCIFIED. FURTHERMORE, THE BALLOON RUPTURED DURING THE FIRST INFLATION FOR 10 SECONDS, AND THE BALLOON WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114386 ↗
• InjuryMay 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURED, AND THEN THE BLOOD VESSEL BURST AND FORMED A HEMATOMA. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS FISTULA ARTERY. A PRESSURE PUMP WAS USED FOR INFLATION, AND A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR BALLOON DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AFTER 17 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED. THE BURST VOLUME WAS 24. CONSEQUENTLY, THE BLOOD VESSEL BURST AND FORMED A HEMATOMA. THE BALLOON WAS REMOVED THROUGH THE SHEATH, AND THE PROCEDURE WAS PAUSED AS MANUAL PRESSING WAS APPLIED ON THE HEMORRHAGE POINT AND THEN DRESSED. THE HEMORRHAGE HAS STOPPED, THE HEMATOMA HAS NOT CONTINUED TO SPREAD, AND THE ANGIOGRAPHY SHOWS THAT THE BLOOD FLOW INSIDE THE CAVITY HAS RECOVERED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 19355341 ↗
• MalfunctionApr 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 5.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS SELECTED FOR USE. WHEN THE BALLOON WAS PREPARED, IT WAS NOTED THAT THE DEVICE WAS ALREADY DAMAGED AND LOOKED LIKE IT HAD BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19218491 ↗
• MalfunctionSep 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE INFLATION, THE BALLOON RUPTURED WITHOUT BEING REACH TO THE MAXIMUM PRESSURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843186 ↗
• MalfunctionJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION BEFORE REACHING THE MAXIMUM PRESSURE, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 75% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS RIGHT UPPER ARM ARTERIOVENOUS SHUNT. THE BALLOON WAS RUPTURED DURING INITIAL INFLATION AT 12 ATMOSPHERES FOR ABOUT 15 SECONDS. THE DEVICE WAS REMOVED FROM THE BODY OVER THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213444 ↗
• MalfunctionNov 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH A NARROW ARTERIOVENOUS FISTULA IN THE RIGHT UPPER LIMB. THE TARGET LESION WAS LOCATED IN THE STENOSED BASILIC VEIN IN THE UPPER ARM. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED TWICE AT 10 ATMOSPHERES (ATM) AND 22 ATM RESPECTIVELY FOR 30-60 SECONDS; HOWEVER, DURING THIRD INFLATION AT 24-26 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15879556 ↗
• MalfunctionOct 12, 2022Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-SEP-2022. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE MORE THAN 95% STENOSED TARGET LESION WAS LOCATED IN LEFT UPPER LIMB. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO DEPLOY AND FOUND THAT CONTRAST AGENT WAS LEAKING AFTER EXITING EXTERNAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH A 6MMX4.0CM, 75CM MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587197 ↗
• MalfunctionJul 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT BALLOON DILATATION OF VASCULAR STENOSIS AT STOMA SITE. A 5.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS BURST UNDER PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15037056 ↗
• MalfunctionJul 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON TEAR OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN UPPER ARM. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON MATERIAL WAS TORN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14938836 ↗
• MalfunctionApr 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH INTRACAVITY STENOSIS AND UNDERWENT ENDOVASCULAR REPAIR OF ARTERIOVENOUS FISTULA. THE TARGET LESION WAS LOCATED IN THE KIDNEY. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AFTER REACHING THE BURST PRESSURE DU TO HIGHLY CALCIFIED LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14244715 ↗
• MalfunctionMar 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN THE LEFT UPPER LIMB. A 5.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. THE DEVICE WAS INFLATED TWICE, HOWEVER, WHEN THE PRESSURE PUMP HIT 22 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE LESION HAS STENOSIS AND THE BALLOON RUPTURED DURING THE FIRST INFLATION FOR 22 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13709093 ↗
• InjuryJun 18, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE ABDOMEN. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. THE BALLOON COULD NOT BE WITHDRAWN SO THE PHYSICIAN THEN CUT THE DELIVERY SYSTEM AND REMOVED THE BALLOON BY SURGICAL INCISION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026272 ↗
• InjurySep 30, 2020Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH ILIAC VEIN COMPRESSION. THE TARGET LESION WAS LOCATED IN THE INFERIOR VENA CAVA. A 5.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED AND COULD NOT BE WITHDRAWN. THE PHYSICIAN THEN CUT THE DELIVERY SYSTEM AND REMOVED THE BALLOON BY SURGICAL INCISION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10606591 ↗
• MalfunctionJun 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL VEIN. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST WHEN THE PRESSURE REACHED TO THE WORKING PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10212843 ↗