XXL™ Vascular M001145320Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08714729190486), received between Jun 10, 2019 and Dec 1, 2025 — classified as 6 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (33 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON LEAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. DURING THE PROCEDURE, ROUTINE LEFT FEMORAL VEIN PUNCTURE WITH A 10F SHEATH WAS PERFORMED. THE GUIDEWIRE AND CATHETER WERE ADVANCED THROUGH THE STENOTIC SEGMENT OF THE LEFT ILIAC VEIN, AND THE GUIDEWIRE ENTERED THE INFERIOR VENA CAVA. A /14-6/5.8/75 XXL WAS FLUSHED AND DELIVERED INTO THE BODY. HOWEVER, UPON BALLOON DILATATION USING A PRESSURED PUMP, A CONTRAST EXTRAVASATION WAS NOTED. UPON WITHDRAWAL, IT WAS NOTED THAT THE BALLOON WAS LEAKING LIQUID, AND IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING A XXL 14 * 60 BALLOON CATHETER. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IDENTIFIED IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678632 ↗
• MalfunctionAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED RIGHT COMMON ILIAC VEIN. A 6/5.8/75 XXL BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED PROXIMAL TO THE TOP OF THE STENT OVER A 0.035 AMPLATZ WIRE. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR 5 SECONDS. UPON DEFLATION, BLOOD WAS OBSERVED RETURNING INTO THE INDEFLATOR. 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 22898362 ↗
• MalfunctionApr 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. PATIENT WAS PRESENTED WITH MAY THURNER'S. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED COMMON ILIAC ARTERY. AFTER GAINING POPLITEAL ACCESS WITH A 9FR SHEATH, AN AMPLATZ WIRE WAS ADVANCED FOLLOWED BY PLACING A NON-BOSTON SCIENTIFIC STENT. A 14-6/5.8/75 XXL VASCULAR WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 5 ATMOSPHERES FOR 1 SECOND, THE BALLOON BURST. THE DEVICE WAS REMOVED INTACT, 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 21850221 ↗
• MalfunctionDec 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH LEFT ILIAC VEIN COMPRESSION AND UNDERWENT STENTING. AFTER FLUSHING, PRE-DILATATION WAS PERFORMED USING A 10X12 MUSTANG BALLOON CATHETER FOLLOWED BY A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER. DURING INFLATION OF THE XXL BALLOON AT 5 ATMOSPHERES, IT WAS NOTED THAT THE LIQUID IN THE PRESSURE PUMP CHANGED FROM TRANSPARENT TO RED, THE PRESSURE WOULD NOT RISE, AND THE LIQUID IN THE PRESSURE PUMP DECREASED. AFTER REMOVAL, A HOLE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904185 ↗
• MalfunctionSep 26, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK IN THE INTRODUCER, AND THE BALLOON BROKE. A 14 MM X 6 CM, 75 CM XXL VASCULAR BALLOON WAS SELECTED FOR AN ARTERIOVENOUS FISTULA (AVF) DILATATION PROCEDURE. WHEN ATTEMPTING TO ADVANCE THE BALLOON THROUGH AN 8 FRENCH NON-BOSTON SCIENTIFIC INTRODUCER, THE BALLOON BECAME STUCK. THE BALLOON THEN BROKE INSIDE THE INTRODUCER WHEN IT WAS ATTEMPTED TO WITHDRAW IT. IT TOOK APPROXIMATELY TEN MINUTES TO RETRIEVE THE BALLOON AND THEN REPLACE THE INTRODUCER AND BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER XXL BALLOON, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310721 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED COMMON ILIAC VEIN. A 4-6/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 3 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528296 ↗
• MalfunctionJul 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED INSIDE AN IMPLANTED STENT. AN XXL VASCULAR BALLOON WAS SELECTED FOR USE TO DILATE AN IMPLANTED STENT. DURING INFLATION, THE BALLOON RUPTURED. ANOTHER XXL BALLOON WAS SELECTED FOR USE. HOWEVER, IT ALSO RUPTURED DURING INFLATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393575 ↗
• MalfunctionJul 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED INSIDE AN IMPLANTED STENT. AN XXL VASCULAR BALLOON WAS SELECTED FOR USE TO DILATE AN IMPLANTED STENT. DURING INFLATION, THE BALLOON RUPTURED. ANOTHER XXL BALLOON WAS SELECTED FOR USE. HOWEVER, IT ALSO RUPTURED DURING INFLATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393511 ↗
• MalfunctionMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED COMMON ILIAC VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON DILATOR WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING THE SECOND INFLATION AT APPROXIMATELY 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580131 ↗
• MalfunctionJan 31, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS SLOW TO DEFLATE. THE PATIENT PRESENTED WITH DEEP VEIN THROMBOSIS AND UNDERWENT STENTING. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS SLOW TO DEFLATE. THE BALLOON WAS REMOVED INTACT AND IN A DEFLATED STATE COMPLETING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272427 ↗
• MalfunctionJan 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WITH A SIGNIFICANT BEND OF <45 DEGREES WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED ILIAC VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION, WHEN REACHED THE STANDARD ATMOSPHERIC PRESSURE, THE CONTRAST AGENT SPILLED, AND THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED DIRECTLY, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN STABLE CONDITION. IT WAS FURTHER REPORTED THAT THE BALLOON WAS RUPTURED AT 5 ATMOSPHERES FOR 10 SECONDS. IN ADDITION, THE DEVICE WAS REMOVED COMPLETELY FROM THE BODY THROUGH A LONG SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196181 ↗
• MalfunctionDec 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH CLAUDICATION AND UNDERWENT LEFT LEG ANGIOGRAM. THE 75% STENOSED TARGET LESION WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED. A 14-6/5.8/75 XXL VASCULAR BALLOON DILATOR WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED SECONDS BEFORE REACHING THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER XXL BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16001559 ↗
• InjuryOct 31, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND REMOVAL DIFFICULTIES OCCURRED RESULTING TO A SURGICAL INTERVENTION. THE TARGET LESION WAS LOCATED IN A FISTULA. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE BALLOON WAS STUCK IN THE VESSEL AND COULD NOT BE REMOVED. THE PATIENT WAS SENT FOR AN OPEN SURGERY TO REMOVE THE BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15698280 ↗
• MalfunctionSep 14, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL VEIN AND A 10F SHEATH WAS INSERTED. AFTER ADVANCING A 260 CM GUIDEWIRE TO THE INFERIOR CAVITY, A CONICAL ARTERY CATHETER WAS EXCHANGED WITH A STIFFENED GUIDEWIRE. A 4-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), IT WAS FOUND THAT THE RATED BURST PRESSURE OF THE BALLOON WAS 8 ATMOSPHERES. HOWEVER, DURING INFLATION, THE PRESSURE COULD NOT GO HIGHER THAN 4 ATMOSPHERES. CONSEQUENTLY, THE BALLOON WAS NOT FULLY INFLATED. UPON WITHDRAWAL, IT WAS FOUND THAT THE BALLOON WAS LEAKING AS THE CONTRAST AGENT HAD MIXED WITH BLOOD. A SYRINGE WAS USED TO INJECT A LIQUID INTO THE BALLOON OUTSIDE THE PATIENT AND A PINHOLE WAS NOTED. THE DEVICE WAS REPLACED WITH A 16X4 XXL VASCULAR BALLOON CATHETER AND THEN A 16X90 BOSTON SCIENTIFIC STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419172 ↗
• MalfunctionJun 29, 2022Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CENTRAL VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED AT ONE LESS WORKING PRESSURE, HOWEVER, UNDER FLUOROSCOPY, IT SHOWS THAT THE CONTRAST WAS SPILLED OVER. THE DEVICE WAS REMOVED, AND A PINHOLE WAS NOTED WHEN CHECKED OUTSIDE THE PATIENT. 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 14861002 ↗
• MalfunctionMay 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS RIGHT ILIAC VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 4 ATMOSPHERES FOR 10-15 SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545114 ↗
• MalfunctionMay 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A LOWER LIMB VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. 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 14278969 ↗
• MalfunctionApr 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON DILATOR WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FULLY INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14029772 ↗
• MalfunctionMar 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, 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 STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926187 ↗
• MalfunctionFeb 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH BILATERAL LEG SWELLING AND UNDERWENT VENOGRAM WITH ILIAC STENT. THE 68% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS COMMON ILIAC VEIN TO COMMON FEMORAL VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION AT 4 ATMOSPHERES FOR 5-10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED WITH A 14X6X75 XXL VASCULAR BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13597725 ↗
• MalfunctionJan 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 92% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ILIAC VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 2 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13403537 ↗
• InjuryJan 25, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED COMMON ILIAC VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INFLATED ONCE IN A PREVIOUSLY IMPLANTED AREA. UPON REMOVAL OF THE DEVICE, IT BECAME STUCK AND WAS CAUGHT ON THE STENT STRUTS. THE DEVICE THEN BROKE OFF. THE ENTIRE PORTION OF THE BALLOON WAS COMPLETELY REMOVED FROM THE OPPOSITE GROIN THROUGH A LARGE SHEATH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13341788 ↗
• MalfunctionDec 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MILD TO MODERATELY TORTUOUS LEFT COMMON ILIAC VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FOURTH INFLATION AT 4 ATMOSPHERES FOR 10 SECONDS OR LESS, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907484 ↗
• MalfunctionNov 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 68% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TO MODERATELY TORTUOUS COMMON AND EXTERNAL ILIAC ARTERY. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813149 ↗
• MalfunctionOct 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 58% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS COMMON ILIAC VEIN. A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE FIRST INFLATION AT 3 ATMOSPHERES FOR 5 SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED FROM THE PATIENT FULLY INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 14X6X75 XXL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697088 ↗