XXL™ Vascular M001145140Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 08714729190462), received between Aug 20, 2018 and Nov 21, 2025 — classified as 5 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (45 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Inflation Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON HOLE OCCURRED. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHEN ATTEMPTED TO INFLATE THE BALLOON, IT DID NOT INFLATE. THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THERE WAS A HOLE. 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 23617170 ↗
• MalfunctionNov 12, 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

  IT WAS REPORTED THAT THE BALLOON BURST AND BECAME ENTANGLED WITH THE TIP OF THE SHEATH. A 14-4/5.8/75 XXL BALLOON CATHETER WAS USED TO TREAT STENOSIS OF THE CENTRAL VEIN IDENTIFIED AFTER ARTERIOVENOUS FISTULA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (AVF PTA) PROCEDURE. HOWEVER, AFTER POSITIONING THE PRODUCT ON THE LESION AND INCREASING PRESSURE TO THE NOMINAL LEVEL, THE BALLOON BURST, CAUSING CONTRAST AGENT LEAKAGE. DURING WITHDRAWAL, THE BALLOON BECAME ENTANGLED WITH THE TIP OF THE SHEATH AND WAS UNABLE TO BE REMOVED. AS A RESULT, THE CATHETER WAS CUT AND REMOVED ALONG WITH 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 WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536556 ↗
• MalfunctionSep 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED CENTRAL VEIN. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON BURST DURING THE FIRST INFLATION BEFORE THE RATED BURST PRESSURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935107 ↗
• MalfunctionJul 24, 2025Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE AND TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VASCULAR ARTERY. A /14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE BEING INFLATED WITHIN THE NOMINAL TO RATED PRESSURE RANGE. THE BALLOON WAS THEN REMOVED, AND IT WAS OBSERVED THAT THE TIP PORTION HAD SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588858 ↗
• MalfunctionJul 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT EXTERNAL ILIAC ARTERY. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS CONTINUED WITH THE ORIGINAL METHOD AND COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523192 ↗
• MalfunctionApr 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS ILIAC ARTERY. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 2 ATMOSPHERES. THE DEVICE WAS REMOVED IMMEDIATELY WITHOUT ANY PROBLEM, 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 21830105 ↗
• MalfunctionSep 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT COMMON ILIAC. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279583 ↗
• InjuryMay 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS RUPTURED AND WAS LEFT INSIDE OF THE PATIENT. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. BEFORE REACHING ITS BURST RATE PRESSURE, THE BALLOON BURST AND SHEARED OFF INSIDE THE PATIENT. THE PIECE OF BALLOON LEFT IN THE PATIENT WAS ABLE TO BE STENTED IN POSITION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19264319 ↗
• MalfunctionNov 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CENTRAL VEIN. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 4 BAR, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072727 ↗
• MalfunctionNov 2, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION WITH A SALINE AND CONTRAST RATIO OF 50:50. HOWEVER, DURING THE PROCEDURE, IT WAS OBSERVED THAT THE BALLOON DEFLATED SLOWLY. THE DEVICE WAS SIMPLY PULLED OUT IN A DEFLATED STATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055953 ↗
• MalfunctionAug 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED AORTA. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550346 ↗
• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH MAY THURNER SYNDROME. THE 57% STENOSED, LARGE DIAMETER WITH SOME ANGULATION TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MILDLY TORTUOUS EXTERNAL ILIAC VEIN. DURING A VENOUS STENT CASE, FIVE XXL VASCULAR BALLOON CATHETERS WERE USED OFF LABEL FOR POST-DILATATION OF AN IMPLANTED VENOUS WALLSTENT. FOUR OF WHICH WERE 16-4/5.8/75 AND ONE 14-4/5.8/75 XXL BALLOON CATHETER. HOWEVER, THE FIRST THREE 16-4/5.8/75 XXL VASCULAR BALLOON CATHETERS WERE RUPTURED BY THE DISTAL STENT EDGE BEFORE ANY INFLATIONS WERE PERFORMED. ANOTHER 16-4/5.8/75 AND 14-4/5.8/75 XXL BALLOON CATHETERS WERE USED AND RUPTURED AT 5 ATMOSPHERES DURING THE INITIAL INFLATION. THE DEVICES WERE REMOVED AND COMPLETED THE PROCEDURE WITH A SOFTER WIRE AND ANOTHER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125643 ↗
• MalfunctionMay 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LEFT ILIAC VEIN. HOWEVER, DURING THE FIRST INFLATION FOR 8 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945256 ↗
• MalfunctionMay 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. 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 16897754 ↗
• MalfunctionApr 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION WITHIN THE NOMINAL RATED PRESSURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765390 ↗
• MalfunctionJan 5, 2023Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A SUBCLAVIAN ARTERY. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. INSTEAD OF USING AN INFLATION DEVICE, THE PHYSICIAN USED A SYRINGE TO INFLATE AND DEFLATE THE BALLOON. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN REMOVING THE BALLOON FROM AN 8F SHORT SHEATH AND CONFIRMED THAT THE BALLOON FAILED TO DEFLATE. THE BALLOON WAS REMOVED IN A PARTIALLY INFLATED STATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109886 ↗
• MalfunctionJan 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED MAY-THURNER SYNDROME. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED COMMON ILIAC VEIN. A 14-4/5.8/75 XXL BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090929 ↗
• InjuryDec 19, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH VENOUS COMPRESSION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT ILIAC VEIN. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED TO REOPEN A PREVIOUSLY PLACED WALLSTENT. HOWEVER, DURING THE INITIAL INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED HORIZONTALLY. A PORTION OF THE BALLOON WAS LEFT IN THE PATIENT AND A SNARE HAD TO BE USED TO RETRIEVE THE REMAINING PIECE. THE PROCEDURE WAS COMPLETED WITH A 12X4 ATHLETIS BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009676 ↗
• MalfunctionNov 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PINHOLE OCCURRED. THE APPROXIMATELY 80% STENOSED TARGET LESION WITH A SIGNIFICANT BEND ABOUT 70% WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CENTRAL VEIN. A 4-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON FAILED TO BE INFLATED AT 8 ATMOSPHERES. HOWEVER, A VISIBLE PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE DEVICE WAS REMOVED COMPLETELY, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797102 ↗
• InjuryApr 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT SOME OF IT SHEARED OFF INSIDE THE PATIENT. SUBSEQUENTLY, THE PHYSICIAN THEN FLOSSED THE WIRE LEFT TO RIGHT AND PUSHED BALLOON OUT WITH A GUIDE CATHETER. THE SHEARED OFF PIECE WAS SUCCESSFULLY RETRIEVED FROM THE GROIN SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160363 ↗
• MalfunctionJan 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14-4/5.8/75 XXL BALLOON DILATOR WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION BEFORE REACHING THE NOMINAL PRESSURE, THE BALLOON RUPTURED. 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 13368709 ↗
• MalfunctionDec 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN CENTRAL VEIN. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION BEFORE REACHING THE RATED BURST PRESSURE AT 3 BAR, THE BALLOON POPPED UP. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY 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 13050974 ↗
• MalfunctionNov 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CENTRAL VEIN. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. THE DEVICE WAS 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 12884573 ↗
• MalfunctionNov 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC VEIN. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, ON INITIAL INFLATION AT 5 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND ANOTHER 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, ON INITIAL INFLATION AT 5 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON ALSO RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 12 X 40 CHARGER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12818769 ↗
• MalfunctionNov 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC VEIN. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, ON INITIAL INFLATION AT 5 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND ANOTHER 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, ON INITIAL INFLATION AT 5 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON ALSO RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 12 X 40 CHARGER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12818683 ↗