Gladiator™ Elite H74939207060440Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 08714729809722), received between Aug 31, 2018 and Dec 31, 2025 — classified as 5 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (48 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD PINHOLES AND WAS LEAKING AIR. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934141 ↗
• InjuryAug 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED AND WAS REMOVED USING UNCONVENTIONAL METHODS. THE TARGET LESION WAS LOCATED IN THE FISTULA VEIN OF THE FOREARM. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AT 18 ATMOSPHERES. CONSEQUENTLY, UNCONVENTIONAL METHODS WERE USED TO REMOVE THE DEVICE. 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 1.1MM VESSEL DIAMETER TARGET LESION WAS NON-CALCIFIED, AND A U-SHAPED ACCESS WAS ESTABLISHED USING THE PUNCTURE NEEDLE TO REMOVE THE DEVICE. FURTHERMORE, THE BALLOON DID NOT SEPARATE WHEN IT BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834193 ↗
• MalfunctionJul 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA OF THE ARTIFICIAL BLOOD VESSEL OF THE LEFT UPPER LIMB. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS DELIVERED THROUGH THE GUIDE WIRE TO DILATE THE STENOSIS PART OF THE VEIN SIDE OF THE ARTIFICIAL BLOOD VESSEL. DURING THE PROCEDURE, THE BALLOON WAS DILATED ONCE AT 10 TO 22 ATMOSPHERES FOR 30 TO 60 SECONDS, AND THE BALLOON WAS DILATED FOR THE SECOND TIME AT 22 TO 24 ATMOSPHERES. HOWEVER, IT WAS FOUND THAT THE PRESSURE WAS REDUCED. THE DEVICE WAS REMOVED, AND THE TIP OF THE BALLOON WAS FOUND TO BE RUPTURED. 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 DEVICE WAS REMOVED WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491171 ↗
• MalfunctionJul 8, 2025Inflation Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12JUN2025. IT WAS REPORTED THAT THE BALLOON WAS DAMAGED AND FAILED TO INFLATE. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN AN ARTIFICIAL ARTERIOVENOUS FISTULA IN THE LEFT UPPER LIMB. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS VISUALLY INSPECTED AND NO DAMAGED WAS FOUND ON THE OUTER PACKAGING. THE DEVICE WAS ADVANCED FOR DILATION INTO THE LESION UNDER GUIDANCE OF COLOR DOPPLER ULTRASOUND. DURING THE PROCEDURE, AN 18 ATM DILATION WAS PERFORMED ONCE. THE DILATION PRESSURE WAS MAINTAINED BELOW THE BURST PRESSURE. IT WAS OBSERVED THAT THE PRESSURE DECREASED DURING THE PROCEDURE. UPON WITHDRAWAL OF THE BALLOON, IT WAS NOTED THAT THE BALLOON WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON LONGITUDINAL TEAR AND TIP DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441085 ↗
• MalfunctionJun 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 A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL IN THE LEFT UPPER LIMB. A 6.0 X40, 40CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SEVENTH INFLATION AT 10 TO 24 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 22333578 ↗
• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE PATIENT WAS PRESENTED WITH ARTIFICIAL ARTERIOVENOUS FISTULA STENOSIS OF LEFT UPPER LIMB. A 6.0 X40, 40CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. THERE WAS NO DAMAGE ON THE OUTER PACKAGING. DURING FIRST INFLATION AT 18 ATMOSPHERES, IT WAS NOTED THAT THE PRESSURE DECREASES. THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY. WHEN CHECKED, IT WAS NOTED THAT THE BALLOON WAS DAMAGED. 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. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 85% STENOSED, MODERATELY TORTUOUS AND MODERATELY CALCIFIED. IT WAS CONFIRMED THAT THE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004516 ↗
• MalfunctionApr 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA OF UPPER LIMB. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS SUCCESSFULLY 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 21778386 ↗
• MalfunctionFeb 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT UPPER LIMB VEIN. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS BURST WHEN THE PRESSURE WAS CONTINUED TO 21 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358496 ↗
• MalfunctionJan 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 2-3CM STENOSED TARGET LESION WITH MILD CALCIFICATION WAS LOCATED 2-3CM ABOVE THE INTERNAL FISTULA ORIFICE. DURING THE PROCEDURE, THE PATIENT WAS SUPINE WITH BRACHIAL PLEXUS ANESTHESIA. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION, BUT THE BALLOON RUPTURED. THE DEVICE WAS SLOWLY RETREATED TO THE SHEATH AND REMOVED, AND 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 21197062 ↗
• MalfunctionNov 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS RUPTURED. THE STENOSED TARGET LESION WAS IDENTIFIED IN THE ARTERIOVENOUS FISTULA OF THE LEFT UPPER LIMB. A 6.0 X 40 MM GLADIATOR ELITE BALLOON CATHETER, WITH A LENGTH OF 40 CM, WAS ADVANCED OVER THE GUIDEWIRE TO DILATE THE STENOSIS ON THE VENOUS SIDE OF THE ARTIFICIAL BLOOD VESSEL. DURING THE PROCEDURE, THE BALLOON WAS INFLATED INITIALLY AT A PRESSURE OF 10-22 ATMOSPHERES FOR A DURATION OF 30-60 SECONDS. IT WAS THEN INFLATED A SECOND TIME AT 22-24 ATMOSPHERES. DURING THIS SECOND INFLATION, A DROP IN PRESSURE WAS OBSERVED, SUGGESTING A POSSIBLE RUPTURE OF THE BALLOON. UPON RETRIEVAL, THE TIP OF THE BALLOON WAS CONFIRMED TO BE BURST. THE DEVICE WAS REMOVED SUCCESSFULLY AND 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 20662133 ↗
• MalfunctionAug 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT FOREARM. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION WHEN DILATED AT 18 ATMOSPHERES FOR ABOUT 15 SECONDS. 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 20057903 ↗
• MalfunctionJul 22, 2024Inflation Problem; Material Rupture; Material Integrity Problem; Failure to Deflate; Inflation Problem; Material Rupture; Material Integrity Problem; Failure to Deflate

  IT WAS REPORTED THAT BALLOON FAILURE TO DEFLATE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, AFTER THE DEVICE ENTERED THE VESSEL, IT COULD NOT DILATE. WHEN IT WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE BALLOON WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793265 ↗
• MalfunctionJun 18, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT FOREARM ARTERIOVENOUS FISTULA. A 6.0 X40, 40CM GLADIATOR BALLOON CATHETER WAS USED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER 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 REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562933 ↗
• MalfunctionMay 14, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM ARTERY. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON CONNECTING THE PRESSURE PUMP AND ROTATING ITS HANDLE, A LEAK BECAME APPARENT AS THE PRESSURE FAILED TO SUSTAIN, CAUSING THE CONTRAST AGENT TO SEEP AROUND THE BALLOON. SUBSEQUENTLY, THE DEVICE WAS REMOVED, REVEALING A PINHOLE-LIKE RUPTURE IN THE INFLATED BALLOON. 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 19315366 ↗
• MalfunctionMay 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE MORE THAN 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED CEPHALIC VEIN. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 22 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED LATERALLY. THE BALLOON WAS PULLED BACK TO THE SHEATH, AND THE GUIDE WIRE, SHEATH AND BALLOON WERE WITHDRAWN TOGETHER. 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 19220942 ↗
• MalfunctionMar 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED FISTULA OF THE WRIST. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON BURST IMMEDIATELY WHEN IT REACHED 20 ATMOSPHERES. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835960 ↗
• MalfunctionDec 21, 2023Material 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 ARM VESSEL. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INFLATION AT 10 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376090 ↗
• MalfunctionSep 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 24 ATMOSPHERES, THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT 50% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED CEPHALIC VEIN. THE BALLOON WAS INFLATED ONCE BEFORE IT BURST AND THE DEVICE WAS DIRECTLY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686439 ↗
• MalfunctionJul 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253447 ↗
• MalfunctionMay 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN LEFT UPPER EXTREMITY. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIFTH INFLATION AT 18 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED IN NORMAL WAY THROUGH THE SHEATH, AND NO DETACHED SEGMENT WAS LEFT INSIDE THE PATIENT'S BODY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017138 ↗
• MalfunctionMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATION. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588633 ↗
• MalfunctionFeb 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED ANASTOMOSIS IN HEMODIALYSIS CHANNEL OF LEFT ARM. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE SECOND INFLATION AT 24 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16450653 ↗
• InjuryFeb 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED RESULTING TO AN ADDITIONAL MEDICAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATELY TO SEVERELY CALCIFIED STENOSIS OF ANASTOMOTIC FISTULA IN A HEMODIALYSIS ACCESS OF THE LEFT ARM. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 24 ATMOSPHERES FOR 30 SECONDS, THE BALLOON PARTIALLY RUPTURED AS THE PRESSURE WAS TOO LARGE. THE DEVICE WAS REMOVED THROUGH SNARING AND 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 16444652 ↗
• MalfunctionFeb 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS AT FISTULA SITE WAS OBTAINED. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE APPLYING PRESSURE ON THE DEVICE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION DIAMETER WAS 2.0MM WITH LENGTH OF 10MM LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED VESSEL. THE DEVICE WAS INFLATED TWICE AT 20 AND 24 ATMOSPHERES RESPECTIVELY. HOWEVER, ON THE THIRD INFLATION AT 24 ATMOSPHERES, THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16344379 ↗
• MalfunctionJan 25, 2023Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20JAN2023. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. VASCULAR STENOSIS WAS OBTAINED AT FISTULA SITE. A 6.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION, BUT THE BALLOON WAS DAMAGED DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON CIRCUMFERENTIAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243174 ↗