Gladiator™ Elite H74939207070470Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729809791), received between Mar 4, 2019 and Dec 30, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (23 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 7.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON HAD RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON OF THE SAME MODEL. THERE WERE 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 23931158 ↗
• MalfunctionNov 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. DURING THE PROCEDURE, A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR LESION DILATATION, AND THE BALLOON WAS PRESSURIZED TO 8 ATM FOR THE FIRST TIME, AND IT WAS FOUND THAT THE BALLOON WAS RUPTURED AND COULD NOT CONTINUE TO EXPAND. AFTER WITHDRAWAL AND EXTERNAL PRESSURE APPLICATION, IT WAS FOUND THAT THE BALLOON WAS OBVIOUSLY LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507005 ↗
• MalfunctionOct 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 A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS PRESSURIZED DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON WAS LEAKING LIQUID AND COULD NOT CONTINUE TO EXPAND. 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 23251130 ↗
• MalfunctionOct 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON LIQUID LEAKAGE WAS FOUND WHEN THE PRESSURE OF THE BALLOON WAS LESS THAN 10 ATMOSPHERES. AFTER THE PRESSURE WAS REMOVED, THE BALLOON WAS REMOVED OF THE BODY, AND THE BALLOON WAS EXPANDED WITH A PRESSURE PUMP, AND IT WAS FOUND THAT THERE WERE THREE SMALL HOLES 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 23251124 ↗
• MalfunctionSep 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 STENOSED TARGET LESION WAS LOCATED IN THE LEFT UPPER LIMB. A 7.0 X40, 75CM GLADIATOR? ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 10 ATMOSPHERES AND WAS OBSERVED TO DISPERSE WITH THE BLOOD FLOW. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY, AND A SMALL HOLE WAS IDENTIFIED ON THE SIDE OF THE BALLOON. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983153 ↗
• MalfunctionJun 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ARTERIOVENOUS FISTULA. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 16 ATMOSPHERES, THE BALLOON BURST. THE BALLOON WAS REMOVED DIRECTLY AFTER PRESSURE RELIEF 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 22142132 ↗
• MalfunctionMar 6, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. THIS 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL FISTULA OF THE FOREARM. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC GUIDE WIRE PUNCTURED THE FRONT END OF THE DELIVERY SHAFT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 21537825 ↗
• MalfunctionSep 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM VEIN. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, AFTER CONNECTING THE PRESSURE PUMP AND ATTEMPTING TO INFLATE THE BALLOON, THE PRESSURE SUDDENLY DROPPED, INDICATING THAT THE BALLOON HAD BROKEN AND RETRACTED. IT WAS NOTED THAT THE BALLOON HAD LONGITUDINAL TEARS AND WAS DIFFICULT TO WITHDRAW. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20318791 ↗
• MalfunctionSep 17, 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 30% STENOSED TARGET LESION WAS LOCATED IN THE UPPER LIMB VESSEL. A 0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON PRESSURE DID NOT REACH THE RIGHT PRESSURE AND THE BALLOON WAS RUPTURED. 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. IT WAS FURTHER REPORTED THAT THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 10 ATMOSPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235595 ↗
• MalfunctionAug 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MAIN CEPHALIC VEIN ABOUT 5 CM ABOVE THE ANASTOMOSIS OF THE LEFT FOREARM ARTERIOVENOUS FISTULA. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON THIRD INFLATION AT 18 TO 20 ATMOSPHERES. THE BALLOON WAS NOTED TO BE FRACTURED IN THE MIDDLE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996035 ↗
• InjuryJul 18, 2024Difficult 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 BALLOON RUPTURE AND DETACHMENT OCCURRED AND WAS DIFFICULT TO REMOVE WHICH REQUIRE ADDITIONAL INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILD CALCIFIED LEFT ANTERIOR DESCENDING. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, UNDER ULTRASOUND IT WAS FOUND THAT BALLOON WAS RETRACTED AND WAS DETERMINED THAT THE BALLOON WAS RUPTURED UPON NINTH INFLATION AT 18 ATMOSPHERES FOR 30 TO 60 SECONDS. THERE WAS A RESISTANCE WHEN THE BALLOON WAS REMOVED WITH THE PUNCTURE SHEATH, UPON REMOVAL A HORIZONTAL FRACTURED WAS NOTED WITH THE BALLOON AND THE REMAINING FRAGMENT COULD NOT BE PULLED OUT. THE SKIN WAS CUT ALONG THE CATHETER PLACEMENT, AND THE BLOOD VESSEL WAS DISSECTIONED. THE BLOOD VESSEL WAS CUT VERTICALLY FOR ABOUT 5MM, THE FRAGMENT WAS SEEN. VASCULAR ANASTOMOSIS WAS PERFORMED AFTER REMOVING THE DETACHED FRAGMENT WITH BLOOD VESSEL FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE BLOOD VESSEL OF LEFT FOREARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773485 ↗
• MalfunctionJul 12, 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 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION WHEN THE PRESSURE REACHED 20 ATMOSPHERES, THE BALLOON BURST. IT WAS WHEN THE DEVICE WAS SIMPLY PULLED OUT WAS THE BURST NOTED. A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731108 ↗
• MalfunctionMar 4, 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 THE LEFT FOREARM ARTERIOVENOUS FISTULA. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE BROKEN. AFTER THE BALLOON WAS REMOVED, THE PHYSICIAN WAS INFORMED THAT THERE WAS A DAMAGE OF ABOUT 3MM IN LENGTH. UPON CAREFUL OBSERVATION, IT WAS SUSPECTED THAT THE CRACK WAS CAUSED BY THE SITUATION THAT TENSION WAS EXCESSIVE, AND THE BALLOON WAS RUPTURED AND COULD NOT BE RESTORED. THE HAND-WASHING NURSE AND THE TRAVELING NURSE IMMEDIATELY SEARCHED AROUND THE STAGE AND THE FLOOR, AND NO MISSING PARTS WERE FOUND. THE PHYSICIAN IMMEDIATELY CAREFULLY EXAMINED THE RELEVANT AREAS OF THE OPERATING FIELD WITH ULTRASOUND AND CONFIRMED THROUGH IMAGING THAT THERE WAS NO FOREIGN BODY IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827149 ↗
• MalfunctionNov 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTIFICIAL ARTERIOVENOUS FISTULA IN LEFT UPPER LIMB. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED OVER A GUIDEWIRE FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT BELOW RATED BURST PRESSURE AT 20 KPA (KILOPASCAL) FOR 40 SECONDS, IT WAS FOUND THAT THE PRESSURE DECREASED AND THE BALLOON BURST. UPON REMOVAL, A LONGITUDINAL BALLOON RUPTURE WAS FOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS POST-PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190387 ↗
• MalfunctionMay 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT FOREARM VESSEL. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED HORIZONTALLY. 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 16957117 ↗
• InjuryNov 8, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED REQUIRING SURGICAL INTERVENTION. THE 40% STENOSED TARGET LESION WITH A <45 DEGREES BEND WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA OF LEFT UPPER LIMB ARTIFICIAL VESSEL. AFTER A GUIDEWIRE WAS CROSSED THE LESION, A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE FIRST INFLATION AT 10 TO 20 ATMOSPHERES FOR 30 TO 60 SECONDS, THE PRESSURE DECREASED AND THE BALLOON BURST. WHEN THE DEVICE WAS REMOVED, IT WAS FOUND OUT THAT THERE WAS A FRAGMENT LEFT IN THE BLOOD VESSEL. THE RESIDUAL END WAS REMOVED BY EMERGENCY INCISION OF THE BLOOD VESSEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15756222 ↗
• MalfunctionApr 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A FISTULA SITE. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON RUPTURED. 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 14118962 ↗
• MalfunctionMar 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A FISTULA OF A VESSEL. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. 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 13866084 ↗
• MalfunctionOct 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE PATIENT PRESENTED WITH VASCULAR STENOSIS AT STOMA SITE. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT UPPER EXTREMITY. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. DURING PRIMING, A BALLOON PINHOLE WAS NOTED. 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 12632732 ↗
• MalfunctionOct 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A LEFT UPPER EXTREMITY. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PRIMING, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT DURING THE FIRST INFLATION IN LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576686 ↗
• MalfunctionMar 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN CENTRAL VEIN. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, WHEN PRESSURE WAS LESS THAN 10 ATMOSPHERES, THE CONTRAST AGENT LEAKED AND THE BALLOON RUPTURED. A HOLE ON THE SIDE OF THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586611 ↗
• MalfunctionSep 8, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14AUG2020. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 7.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED LONGITUDINAL BALLOON TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10503252 ↗
• MalfunctionOct 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A LEFT ARTERIOVENOUS FISTULA. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REPLACED WITH ANOTHER 8.0 X40, 75CM 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. IT WAS FURTHER REPORTED THAT THERE WAS A GREATER THAN 90% STENOSIS, WITH NON-CALCIFIED TARGET LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152992 ↗
• MalfunctionAug 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON INFLATION, IT WAS NOTED THAT THERE WAS A SMALL LEAK AT THE DISTAL PORTION OF THE BALLOON. AFTER REMOVING THE DEVICE, A VISIBLE PINHOLE ON THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT DURING INFLATION AT 10-12 ATMOSPHERES, A LEAK WAS NOTED ON FLUOROSCOPY AND THE BALLOON WAS UNABLE TO HOLD PRESSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8911708 ↗
• MalfunctionAug 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. A 7.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON INFLATION, IT WAS NOTED THAT THERE WAS A SMALL LEAK AT THE DISTAL PORTION OF THE BALLOON. AFTER REMOVING THE DEVICE, A VISIBLE PINHOLE ON THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8911706 ↗