MUSTANG™ H74939171040410Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729793557), received between Nov 8, 2018 and Sep 21, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (30 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Rupture

  It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified Iliac artery. A 4.0 x 40, 135cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at 20 atmospheres for 30 seconds. The device was removed without any problem using the normal method, and the procedure was completed with a different device. There were no patient complications as a result of this event, and the patient was in good condition post-procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836665 ↗
• MalfunctionJun 5, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILLIAC. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 7 ATMOSPHERES FOR 2 SECOND. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS 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 25418022 ↗
• MalfunctionMay 28, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 4.0 X 40, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED DURING FIRST INFLATION. THE BALLOON WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY BY SIMPLY REMOVING IT, 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 IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322674 ↗
• 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 A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 18 ATMOSPHERES FOR 1 MINUTE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS 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 22182966 ↗
• MalfunctionApr 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION ALONG WITH THE GUIDEWIRE. DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON BURST. 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 21917064 ↗
• MalfunctionFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RENAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364162 ↗
• MalfunctionJun 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE RIGHT FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, BALLOON DID NOT EXPANDED. AFTER THE BALLOON WAS WITHDRAWN, IT WAS NOTED THAT THE BALLOON WAS BROKEN AND LEAKING AIR IN VITRO. THE PROCEDURE WAS COMPLETED WITH SAME OF ANOTHER DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE. IT WAS FURTHER REPORTED THAT THE 70% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT FEMORAL ARTERY. DURING INFLATION FOR ABOUT 2 MINUTES AT 12 ATMOSPHERES THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577082 ↗
• MalfunctionMar 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS FISTULA. A 4MM X 40MMX 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 2 MINUTES. THE DEVICE WAS REMOVED SUCCESSFULLY AND THERE WERE NO FRAGMENTS LEFT INSIDE 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 18966456 ↗
• MalfunctionMar 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED IN THE MIDDLE PART UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852714 ↗
• MalfunctionJan 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425895 ↗
• MalfunctionNov 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 4.0 X 40, 135CM MUSTANG WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE IT WAS NOTED THAT THE BALLOON RUPTURED AT THE MIDDLE IN PINHOLE FORM, AT 10 ATMOSPHERES FOR 3 SECONDS UPON FIRST INFLATION. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102174 ↗
• MalfunctionJun 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT AROUND 2 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17233002 ↗
• MalfunctionApr 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 4 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED 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 16710870 ↗
• MalfunctionOct 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ABDOMINAL ANEURYSM. THE TARGET LESION WAS MODERATELY TORTUOUS. AFTER A GUIDING SHEATH WAS TRIED TO ADVANCE NEAR THE LESION BUT FAILED, A V-18 WAS CROSSED THE LESION. A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDING SHEATH WAS TRIED TO ADVANCE WHILE ANCHORING A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER FOR DILATION. IT WENT SMOOTHLY ON THE FIRST THREE ATTEMPTS, HOWEVER, DURING THE FOURTH DEFLATION, THE BALLOON RUPTURED. THE GUIDING SHEATH WAS ABLE TO DELIVER ALMOST TO THE TARGET LESION, AND ADDITIONAL BALLOON WAS NOT USED. A NON-BSC DEVICE WAS USED FOR DELIVERY ALONG WITH THE V-18 GUIDEWIRE. IT WAS NOTICED THAT THERE WAS A KINK ON THE V-18 GUIDEWIRE AND DELIVERY WAS DIFFICULT. V-18 WAS REPLACED WITH A NEW ONE AND THEN A NON-BSC DEVICE WAS DELIVERED AND PLACED. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS NOR INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15573038 ↗
• MalfunctionAug 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292505 ↗
• MalfunctionMay 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED THREE TIMES AT 24 ATMOSPHERES EACH FOR 10 SECONDS RESPECTIVELY, HOWEVER, DURING THE THIRD INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438838 ↗
• MalfunctionMay 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED AT THE DISTAL TIP PROXIMAL PART. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437909 ↗
• MalfunctionApr 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED DURING INCREASING PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14244623 ↗
• MalfunctionDec 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112904 ↗
• MalfunctionOct 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 24 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706981 ↗
• MalfunctionOct 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND WAS FOUND TO BE VERTICALLY SPLIT IN THE MIDDLE OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651453 ↗
• MalfunctionSep 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED IN A FORM OF VERTICAL SPLIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544087 ↗
• MalfunctionMay 26, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT BALLOON INFLATION FAILURE AND LEAK OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING AN UPPER ARM APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, THE BALLOON FAILED TO INFLATE. WHEN REMOVED, A LEAK IN THE CONTRAST MEDIA WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891137 ↗
• MalfunctionFeb 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PREDILATON. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED AND DILATATION WAS PERFORMED USING A 4MM BALLOON. FOLLOWING DEPLOYMENT OF A 7.0 X 80 ELUVIA DRUG-ELUTING STENT, POST-DILATATION WAS PERFORMED WITH A 6.0 X 40, 135CM MUSTANG BALLOON CATHETER. HOWEVER, DURING INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279768 ↗
• MalfunctionOct 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0 X 40MM, 75CM AND 4.0 X 40MM, 135CM MUSTANG BALLOON CATHETERS WERE SELECTED FOR USE. HOWEVER, DURING INITIAL INFLATION AT 24 ATMOSPHERES, THESE BALLOONS RUPTURED. BOTH DEVICE WERE REMOVED AND A PINHOLE WAS NOTED ON BOTH BALLOONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10615150 ↗