Gladiator™ Elite H74939207060470Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 08714729809739), received between Jan 18, 2019 and Aug 14, 2026 — classified as 5 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (63 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 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254252 ↗
• MalfunctionMar 22, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE FOREARM VESSEL. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 22 ATMOSPHERES. 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 24658984 ↗
• MalfunctionMar 19, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 58% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN ARTERY. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST PRESSURE EXPANSION OF THE LESION, A PRESSURE OF 16 ATMOSPHERES WAS APPLIED AND THE BALLOON EXPANDED NORMALLY WHILE MAINTAINING THE PRESSURE. DURING THE SECOND EXPANSION OF THE LESION, A PRESSURE OF 10 ATMOSPHERES WAS APPLIED BUT THE BALLOON FAILED TO MAINTAIN THE PRESSURE. IMMEDIATELY, THE PRESSURE WAS RELEASED, AND THE BALLOON WAS REMOVED. 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 24641784 ↗
• MalfunctionMar 17, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 22 ATMOSPHERES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615416 ↗
• MalfunctionDec 25, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL BALLOON INFLATION, THE BALLOON COULD NOT BE PRESSURIZED OR EXPANDED. AFTER REMOVAL FROM THE PATIENT, THE BALLOON WAS FOUND TO BE RUPTURED AND LEAKING FLUID. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN, AND THE BALLOON BURST AT 10 ATMOSPHERES DURING A 15 SECOND INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892356 ↗
• MalfunctionDec 5, 2025Fluid/Blood Leak; Inflation Problem; Material Rupture; Fluid/Blood Leak; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, DURING PRESSURIZATION OF THE BALLOON TO 8 ATMOSPHERES (ATM), A RUPTURED WAS NOTED AND THE BALLOON COULD NOT CONTINUE TO EXPAND. UPON REMOVAL, IT WAS OBSERVED THAT THE BALLOON WAS LEAKING LIQUID AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VEIN. THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 3 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733485 ↗
• MalfunctionNov 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS ULTRASOUND-GUIDED BALLOON ANGIOPLASTY OF THE LEFT FOREARM ARTERIOVENOUS FISTULA UNDER REGIONAL BLOCK ANESTHESIA. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 6.0 X 40 MM, 75 CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED THREE TIMES: FIRST AT 18 ATM FOR 30 SECONDS, SECOND AT 20 ATM FOR 30 SECONDS, AND THIRD AT 24 ATM, DURING WHICH THE BALLOON RUPTURED. THE BALLOON RUPTURE WAS DETECTED WHILE INFLATING THE CATHETER USING A PRESSURE PUMP AFTER IT HAD BEEN PROPERLY POSITIONED IN THE VESSEL. THE PHYSICIAN IMMEDIATELY REMOVED THE CATHETER AND, TOGETHER WITH THE SCRUB AND CIRCULATING NURSES, INSPECTED THE DEVICE, FINDING THE BALLOON RUPTURED INTO TWO SEGMENTS WITH CLEAN, SMOOTH EDGES. THE HEAD NURSE WAS PROMPTLY NOTIFIED. AN ULTRASOUND EXAMINATION OF THE TREATED VESSEL CONFIRMED THAT NO FOREIGN MATERIAL REMAINED INSIDE. THE TWO RUPTURED SEGMENTS WERE BROUGHT TOGETHER BY BENDING THE CATHETER, AND THE ENDS MATCHED PERFECTLY, CONFIRMING THAT NO FRAGMENTS WERE MISSING. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543159 ↗
• MalfunctionOct 27, 2025Fluid/Blood Leak; Leak/Splash; Material Rupture; Fluid/Blood Leak; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE GREATER THAN 50% STENOSED VESSEL. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS WITHDRAWN FROM THE PATIENT AND PRESSURIZED, IT WAS NOTED THAT THE BALLOON WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE ARM. ADDITIONALLY, THERE WERE NO PHYSICAL DAMAGE NOTED TO THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388749 ↗
• MalfunctionOct 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS PRESSURIZED AT 10 ATMOSPHERES, THE BALLOON RUPTURED. AFTER THE PRESSURE WAS REMOVED, THE BALLOON WAS TAKEN OUT OF THE BODY, AND THE BALLOON WAS EXPANDED WITH A PRESSURE PUMP. IT WAS FOUND THAT THERE WERE 2-3 SMALL HOLES, AND IT WAS LEAKING LIQUID FROM THE BALLOON. 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 23251119 ↗
• InjuryAug 8, 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, AND ADDITIONAL INTERVENTION WAS PERFORMED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT FOREARM. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON THIRD INFLATION AT 24 ATMOSPHERES. SUBSEQUENTLY, THE PHYSICIAN PERFORMED AN INTERVENTION VIA SURGERY TO REMOVE THE REMNANTS OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN PERFORMED OPEN SURGERY, CUT THROUGH THE SKIN AND VESSEL TO REMOVE THE REMAINING OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749210 ↗
• MalfunctionAug 5, 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 PATIENT UNDERWENT BALLOON DILATION AND ANGIOPLASTY IN THE INTERVENTIONAL ROOM DUE TO STENOSIS OF THE ARTERIOVENOUS FISTULA IN THE RIGHT UPPER LIMB. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SECOND INFLATION AT 20 ATMOSPHERES. 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 22719730 ↗
• MalfunctionAug 5, 2025Fluid/Blood Leak; Inflation Problem; Leak/Splash; Fluid/Blood Leak; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON WAS LEAKING AIR. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED VESSEL. A 6.0 X40, 75CM GLADIATOR? ELITE WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON LEAKED AIR AND COULD NOT BE INFLATED DURING THE FIRST PRESSURIZATION DURING THE PROCEDURE. 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 22711992 ↗
• MalfunctionJun 11, 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 67% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED NOBLE VEIN OF LEFT UPPER LIMB. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED TO 20 ATMOSPHERES; HOWEVER, THE DEPRESSION ON THE IMAGE WHEN VESSEL WAS COMPRESSED DID NOT DISAPPEAR. THEREFORE, THE BALLOON WAS INFLATED AGAIN AT 23 ATMOSPHERES, HOWEVER, THE BALLOON RUPTURED. 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 22188711 ↗
• MalfunctionJun 3, 2025Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED. THE PATIENT WAS IN CHRONIC RENAL FAILURE UREMIA HEMODIALYSIS STATE. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ARTIFICIAL ARTERIOVENOUS FISTULA OF THE LEFT UPPER LIMB. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED TO 20P, AND THE PRESSURE WAS RELEASED. SUBSEQUENTLY, UPON WITHDRAWING THE BALLOON, IT WAS NOTED THAT THE BALLOON AND THE SHAFT ADHERED AND COULD NOT BE WITHDRAWN. UPON PULLING, IT WAS NOTED THAT THE FRONT END OF THE DELIVERY SHAFT WAS FRACTURED. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132873 ↗
• MalfunctionApr 3, 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 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ARTIFICIAL ARTERIOVENOUS FISTULA IN LEFT UPPER LIMB ARTERY. A 6.0 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 21770084 ↗
• InjuryApr 2, 2025Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem

  THE BALLOON WAS BURST AND ADDITIONAL INTERVENTION WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA OF LEFT UPPER EXTREMITY. A 6.0 X40, 75CM GLADIATOR ELITE WAS USED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED TRANSVERSELY, CAUSING SOME PIECES TO BECOME DIFFICULT TO REMOVE. AS A RESULT, A PARTIAL INCISION OF THE BLOOD VESSEL WAS MADE TO EXTRACT THE BROKEN DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753088 ↗
• MalfunctionMar 19, 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 TARGET LESION WAS LOCATED IN A VESSEL OF THE LEFT UPPER LIMB. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS PLACED ALONG THE GUIDEWIRE TO THE LESION. DURING INFLATION AT 22 ATMOSPHERES, THE BALLOON RUPTURED. 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 21646739 ↗
• MalfunctionMar 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST UPON INITIAL INFLATION AT 9 ATMOSPHERES FOR 2 MINUTES. THE DEVICE WAS REMOVED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED WITH NON-BOSTON SCIENTIFIC DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620244 ↗
• MalfunctionMar 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED FISTULA. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED SUCCESSFULLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515033 ↗
• MalfunctionJan 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE UPPER LIMB VEINS. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST WHEN PRESSURE REACHED 20 ATMOSPHERES THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144730 ↗
• MalfunctionJan 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE THROMBOSIS OF ARTERIOVENOUS FISTULA. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. 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 21123802 ↗
• MalfunctionDec 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED BEFORE REACHING THE BURST-RATED PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING FIRST INFLATION IN LESS THAN 30 SECONDS DURING THE PROCEDURE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH ALTERNATE GLADIATOR BALLOON. THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20937385 ↗
• MalfunctionDec 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X 40, 75 CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. A 5F MINI-CATHETER SHEATH WAS SUCCESSFULLY INSERTED INTO THE LEFT RADIAL ARTERY, 1 CM PROXIMAL TO THE WRIST JOINT, USING THE SELDINGERMETHOD. A 6F VASCULAR SHEATH WAS THEN INSERTED WITH THE 6F GUIDE WIRE, AND 3000U OF HEPARIN WAS ADMINISTERED INTRAVENOUSLY. THE GUIDE WIRE WAS SMOOTHLY ADVANCED TO THE PROXIMAL END OF THE CEPHALIC VEIN. THE 4 X 40MM, 75CM GLADIATOR BALLOON WAS DELIVERED AND INFLATED AT 24 ATM FOR 30 SECONDS TO TREAT THE OCCLUSION AND STENOSIS IN THE CEPHALIC VEIN. HOWEVER, A FOLLOW-UP ULTRASOUND REVEALED INSUFFICIENT DILATION, SO A 6 X 40MM, 75CM GLADIATOR BALLOON WAS USED. DURING INFLATION TO 20 ATM, THE PRESSURE DROPPED, INDICATING A BALLOON WAS BROKEN. A REPLACEMENT BALLOON WAS USED, AND THE PRESSURE WAS INCREASED TO 24 ATM FOR 30 SECONDS, THE OCCLUSION AND STENOSIS OF CEPHALIC VEIN WERE FULLY DILATED. AFTER WITHDRAWING THE CATHETER AND GUIDE WIRE, THE SHEATH WAS REMOVED, AND LOCAL PRESSURE BANDAGING WAS APPLIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904320 ↗
• MalfunctionNov 27, 2024Inflation Problem; Inflation Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 07NOV2024. IT WAS REPORTED THAT A BALLOON PINHOLE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT UPPER ARTERIOVENOUS. A 6.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS DILATED ONCE AT 16 ATM, WHICH REMAINED BELOW THE BURST PRESSURE. FOLLOWING THIS, THE PRESSURE WAS REDUCED, AND THE BALLOON WAS WITHDRAWN. UPON INSPECTION, THE BALLOON WAS FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE LOCATED APPROXIMATELY 7MM DISTAL OF THE PROXIMAL MARKER BAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797452 ↗
• MalfunctionNov 19, 2024Material 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 TARGET LESION WAS LOCATED IN A FOREARM VESSEL. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE BALLOON WAS INFLATED TO 20 ATMOSPHERES, THE BALLOON RUPTURED AND COULD NOT BE EXPANDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MODERATELY VESSEL. THE BALLOON RUPTURED UPON FIRST INFLATION FOR 30 SECONDS. THE DEVICE WAS REMOVED NORMALLY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729464 ↗