MUSTANG™ H74939171120670Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729794738), received between Sep 2, 2019 and Apr 21, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT DEVICE DIFFICULT TO ADVANCE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA (AVF). A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A LOT OF RESISTANCE WHEN THE DEVICE ADVANCE IN SHEATH. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945319 ↗
• MalfunctionMar 31, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12MAR2026. IT WAS REPORTED THAT RESISTANCE WAS FELT UPON ADVANCING INTO THE SHEATH. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING ADVANCING INTO THE SHEATH, A LOT OF RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT A LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741165 ↗
• MalfunctionFeb 10, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE BALLOON WAS RUPTURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA (AVF). THE BALLOON RUPTURED UPON THIRD INFLATION FOR 1 MINUTE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308021 ↗
• MalfunctionDec 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 12.0 X 60, 75CM MUSTANG WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST WHILE INFLATING IT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678559 ↗
• MalfunctionMay 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION, EXHIBITING 70% STENOSIS, WAS LOCATED IN A VESSEL WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE BALLOON WAS INFLATED ONCE, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034813 ↗
• MalfunctionDec 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE REACHING RATED BURST PRESSURE. 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 20938494 ↗
• MalfunctionJul 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SHUNT VEIN. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS BURST BEFORE REACHING NOMINAL BURST PRESSURE (NBP). THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 19669296 ↗
• MalfunctionMay 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CENTRAL VEIN. A 12.0 X 60, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322000 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC VEIN. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE MIDDLE PART OF THE BALLOON BURST UPON SECOND INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE CONTRAST AGENT WAS LEAKING OUT AFTER SEVERAL ATTEMPTS OF DILATION. THE PHYSICIAN DETERMINED THAT THE PROCEDURE COULD NOT BE PERFORMED WITH THIS DEVICE. A DIFFERENT SIZE OF MUSTANG BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531816 ↗
• MalfunctionSep 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED CENTRAL VENOUS VESSEL. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON REACHING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR LESS THAN 30 SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793977 ↗
• MalfunctionAug 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE CENTRAL VEIN, A MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION WHILE REACHING THE RATED BURST PRESSURE, THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED. FURTHERMORE, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 18 ATMOSPHERES FOR 40 SECONDS. NEITHER THE BALLOON NOR A SEGMENT OF THE BALLOON DETACHED INSIDE THE PATIENT AFTER IT RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE RUPTURED DEVICE USED DURING PROCEDURE WAS A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561398 ↗
• MalfunctionFeb 1, 2023Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT SLOW DEFLATION OCCURRED. THE 100% STENOSED TARGET LESION WITH A SIGNIFICANT BEND OF <45 DEGREES WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON EXPANDED SLOWLY DURING INFLATION. ADDITIONALLY, DURING DEFLATION, THE BALLOON DEFLATION TIME WAS TOO SLOW. THE BALLOON WAS INFLATED TWICE BEFORE IT WAS NOTED THAT IT WAS DIFFICULT TO BE DEFLATED. NO SYMPTOMS OBSERVED IN THE PATIENT'S BODY WHILE THE BALLOON REMAINED INFLATED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY IN DEFLATED STATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279844 ↗
• MalfunctionJan 4, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION PROBLEM OCCURRED. THE PATIENT PRESENTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS TOO SLOW TO DEFLATE. THE BALLOON WAS REMOVED INTACT AND IN A DEFLATED STATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099244 ↗
• MalfunctionNov 28, 2022Material Rupture; Device-Device Incompatibility; Material Rupture; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. IT WAS NOTED THAT THE BALLOON SEEMED TO HAVE TOUCHED THE STENT TIP AND CONTRAST WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869231 ↗
• MalfunctionNov 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED BY PULLING BACK AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725442 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED THAT A BREAK OCCURRED. A 12.0 X 40, 135CM MUSTANG CATHETER WAS BEING USED FOR DILATION OF THE VENOUS ILIAC. THE BALLOON WAS INFLATED AND AFTER A FEW MINUTES, THE BALLOON BURST. A 12.0 X 60, 75CM MUSTANG CATHETER WAS USED; HOWEVER THE CARRIER BROKE IN THE MIDDLE OF THE BALLOON DURING THE PASSAGE OF THE FIBROUS LESION. THE BALLOON AND THE GUIDE ASSEMBLY WERE REMOVED FROM THE PATIENT. THE VASCULAR PATH WAS LOST AND THE INTERVENTION WAS INTERRUPTED. NO OTHER SURGICAL INTERVENTION WAS PLANNED FOR THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868671 ↗
• MalfunctionOct 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED INTO THE VENA CAVA FOR DILATION. THE BALLOON WAS INFLATED TWICE; HOWEVER, THE PRESSURE DID NOT INCREASE. THE BALLOON WAS TAKEN OUT AND WAS CHECKED OUTSIDE THE PATIENT'S BODY. THERE WAS A LEAK IN THE BALLOON. THE BALLOON WAS REPLACED WITH ANOTHER OF SAME DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584577 ↗
• MalfunctionSep 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUBCLAVIAN VEIN. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 4 ATMOSPHERES, CONTRAST LIQUID SUDDENLY APPEARED AT THE PROXIMAL BALLOON AND THE BALLOON WOULD NOT EXPAND WHICH INDICATED A BALLOON BURST. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 40% STENOSED. THE BALLOON WAS INFLATED ONCE FOR 20 SECONDS AND THE BALLOON SEGEMENT DID NOT COME OFF. THE DEVICE WAS RELEASED AS USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422886 ↗
• MalfunctionJul 16, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28JUN2021. IT WAS REPORTED THAT BALLOON LEAKAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION, BUT THERE WAS CONTRAST AGENT LEAKING WHEN THE BALLOON WAS INFLATED. THE BALLOON COULD NOT REACH TO THE NORMAL PRESSURE AND COULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180676 ↗
• MalfunctionJul 14, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-JUN-2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE LONG SEGMENT TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN RETURN IN UPPER ARM. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON COULD NOT REACH THE NOMINAL PRESSURE AND CONTRAST AGENT WAS SPILLED. DILATION EFFECT WAS NOT ACHIEVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167262 ↗
• InjuryDec 14, 2020Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON RUPTURE AND DEVICE DETACHMENT OCCURRED. THE PATIENT PRESENTED FOR A FISTULOGRAM. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS INTRODUCED. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AND FRAYED. THE DEVICE WAS REMOVED BUT REMNANTS WERE LEFT INSIDE THE PATIENT AND THE PATIENT WAS SENT TO SURGERY. THE PROCEDURE WAS NOT COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11004586 ↗
• MalfunctionOct 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN CENTRAL VEIN. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10695569 ↗
• MalfunctionOct 6, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN TRIED TO SWITCH TO A 10ML SYRINGE TO DEFLATE BUT IT WAS UNSUCCESSFUL. THE BALLOON WAS INFLATED AGAIN AND THEN WAS ABLE TO BE DEFLATED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638034 ↗
• MalfunctionOct 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. DURING ARTERIOVENOUS FISTULA ANGIOPLASTY, A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS LEAKING FROM THE PROXIMAL LEFT SIDE OF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10631235 ↗
• MalfunctionJul 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUBCLAVIAN VEIN. A 12.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION UP TO 4 ATMOSPHERES FOR 3-5 SECONDS, CONTRAST LIQUID SUDDENLY APPEARED ON THE PROXIMAL BALLOON AND THE BALLOON COULD NOT EXPAND. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE LESION WAS NON-TORTUOUS AND NON-CALCIFIED WITH 60% STENOSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10351963 ↗