Armada B1050-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 08717648154607), received between Dec 1, 2016 and May 1, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (37 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS ARTERIOVENOUS FISTULA LESION WITH 80% STENOSIS. A 5X40 MM ARMADA 35 PTA BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION. HOWEVER, DURING INFLATION, THE BALLOON WAS UNABLE TO REACH 22 ATM DUE TO A LEAK IN THE DELIVERY ROD "[SHAFT]". AN ADDITIONAL 5X40 MM ARMADA 35 PTA BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058141 ↗
• MalfunctionJan 15, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ARTERIOVENOUS FISTULA STENOSIS WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE 5X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 22 ATMOSPHERES AND THEN ONCE TO 20 ATMOSPHERES AND RUPTURED. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083520 ↗
• MalfunctionJan 5, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE AV FISTULA. THE 5X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS FOUND TO HAVE ABNORMAL PRESSURE AND AFTER REPEATED ADJUSTMENTS BY THE PHYSICIAN, AIR BUBBLES WERE OBSERVED FROM THE HUB, PREVENTING THE PRESSURE FROM RISING. THE BALLOON WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961421 ↗
• MalfunctionDec 29, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND NO TORTUOSITY. AN AMPLATZ GUIDE WIRE BECAME STUCK INSIDE THE HUB OF ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE DEVICES WERE REMOVED TOGETHER. ANOTHER ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907946 ↗
• MalfunctionNov 3, 2025Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method; Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THE HEMODIALYSIS ACCESS DILATION SURGERY THE 5.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE PATIENT ANATOMY AND WHEN THE DEVICE WAS PURGED, SMALL BUBBLES WERE NOTED. WHEN THE BALLOON WAS INFLATED THREE TIMES TO 8 ATMOSPHERES, THE BALLOON FILLED UNEVENLY AND CONTAINED MANY SMALL BUBBLES; WHICH LED THE PHYSICIAN TO MAKE A POOR JUDGMENT ON THE EFFECTIVENESS OF THE SURGICAL DILATION. ANOTHER ARMADA 35 BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451461 ↗
• MalfunctionSep 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT FOREARM AUTOGENOUS ARTERIOVENOUS FISTULA. THE 5X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE AND RUPTURED AT THE RATED BURST PRESSURE. THE BALLOON WAS REMOVED AND IMMEDIATELY REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965339 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. DURING INFLATION OF A 5X40MM ARMADA 35 BALLOON, CONTRAST WAS LEAKING FROM THE CATHETER HUB AND THE REQUIRED PRESSURE COULD NOT BE REACHED. THERE WAS NO DAMAGE OBSERVED ON THE BALLOON. A NEW ARMADA 35 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22933262 ↗
• MalfunctionAug 26, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 5X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) A HAIR ON THE SHAFT OF THE DEVICE WAS NOTED. THEREFORE THE BDC WAS REPLACED WITH A NEW ARMADA 35 BDC AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896917 ↗
• MalfunctionJul 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT COMMON ILIAC ARTERY. A 5X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED WITHOUT ISSUE. DURING PRE-DILATATION, THE BALLOON WAS RUPTURED AT 15 ATMOSPHERES (ATM) DURING THE INITIAL INFLATION. A NEW 5X20MM ARMADA BDC WAS USED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462543 ↗
• MalfunctionMay 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION THE ARTERIOVENOUS FISTULA. THE 5 X 40 MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 20 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND AN UNSPECIFIED BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106985 ↗
• MalfunctionApr 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS ARTERIOVENOUS FISTULA WITH STENOSIS. A 5 X 40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 21ATMS. THEREFORE, THE BDC WAS REMOVED AND ANOTHER SAME SIZED ARMADA 35 BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858233 ↗
• MalfunctionDec 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 5X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 2 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895302 ↗
• MalfunctionNov 21, 2024Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ARTERIOVENOUS FISTULA STENOSIS WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 70% STENOSIS. THE 5X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO 2 ATMOSPHERES ON THE FIRST INFLATION; HOWEVER, THE PRESSURE OF THE BALLOON WOULD NOT CONTINUE TO INCREASE AND THE BALLOON PARTIALLY INFLATED. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS A TEAR/HOLE ON THE TOP AND BOTTOM OF THE INNER AND OUTER MEMBERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747190 ↗
• MalfunctionAug 26, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE ILIAC ARTERY. THE 5MMX40MM ARMADA 35 BALLOON DILATATON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION; HOWEVER, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED, AND A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064459 ↗
• MalfunctionFeb 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION THROUGH ANASTOMOSIS IN THE RADIOCEPHALIC ATRIOVENTRICULAR (AV) FISTULA WITH CALCIFICATION. THE 5.0X40 ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND INFLATED TWICE, 10 ATMOSPHERES (ATMS) AND 18 ATMS, HOWEVER, THE BALLOON RUPTURED. ANOTHER ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696567 ↗
• MalfunctionNov 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CEPHALIC VEIN. THE 5X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED WHEN IT WAS INFLATED ONCE AND REACHED 16 ATMOSPHERES. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18164851 ↗
• MalfunctionNov 13, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS AV FISTULA THAT IS 70% STENOSED. THE 5.0X40MM ARMADA BALLOON DILATATION CATHETER WAS INFLATED TO 11 ATMOSPHERES AND LEAKAGE OF CONTRAST AGENT WAS NOTED COMING FROM THE PROXIMAL SHAFT. A TEAR WAS NOTED AT THE PROXIMAL SHAFT. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120471 ↗
• MalfunctionOct 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS ATRIOVENTRICULAR FISTULA THAT IS 60% STENOSED. A 5X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 20 ATMOSPHERES DURING THE SECOND INFLATION. ANOTHER SAME SIZE ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913821 ↗
• MalfunctionSep 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% RE-STENOSED ARTERIOVENOUS FISTULA THAT WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. REPORTEDLY, WHEN THE 5.0X40MM ARMADA BALLOON WAS PRESSURED TO 20 ATMOSPHERES, THE BALLOON RUPTURED. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674620 ↗
• MalfunctionAug 21, 2023Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY CALCIFIED ATRIOVENTRICULAR FISTULA THAT IS 70% STENOSED. THE 5X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS INFLATED TWICE AT 14 ATMOSPHERES AND COMPLETELY DEFLATED TWICE AFTER 40 SECONDS IN NEGATIVE HELD; HOWEVER, THE BALLOON MET RESISTANCE DURING REMOVAL WITH THE GUIDE WIRE. THEREFORE, BOTH WERE REMOVED AS ONE UNIT AND ONCE OUTSIDE THE ANATOMY THE SHAFT OF THE BALLOON WAS NOTED BENT. ANOTHER ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17587578 ↗
• MalfunctionJul 6, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT SUPERIOR FEMORAL ARTERY (PSFA) WITH MODERATE CALCIFICATION AND NONE TORTUOSITY. THE 6.0X60MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS IMPLANTED. AFTER IMPLANTATION, IT WAS OBSERVED THAT THE PROXIMAL AND DISTAL PORTIONS OF THE STENT WERE NOT FULLY DEPLOYED. THE 5X40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED FOR POST DILATATION. THE BALLOON WAS INFLATED ONCE AT 12 ATMOSPHERES. DURING REMOVAL, RESISTANCE WAS MET WITH THE STENT STRUTS. SEVERAL ATTEMPTS WERE NEEDED TO REMOVE THE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17268942 ↗
• MalfunctionMay 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE 5.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND THE BALLOON WAS INFLATED 3 TIMES AT 6 ATMOSPHERES (ATMS) FOR EACH INFLATION WHEN IT WAS NOTED TO BE LEAKING. ANOTHER BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. ALTHOUGH THERE WERE REPORTED DELAYS IN THE PROCEDURE, IT WAS CONFIRMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS; THEREFORE THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003008 ↗
• MalfunctionMar 9, 2023Material Rupture; Material Rupture

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED. RETURN DEVICE ANALYSIS FOUND THERE WERE NO DAMAGES NOTED TO THE BDC. THE ACCOUNT CONFIRMED THAT THE INCORRECT BDC WAS RETURNED AND THE REPORTED BDC WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16516643 ↗
• MalfunctionDec 21, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 5X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), NEGATIVE WAS PULLED ON THE SYRINGE RESULTING IN LOTS OF CONTINUOUS AIR BUBBLES. A LEAK WAS SUSPECTED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW ARMADA 35 BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028694 ↗
• MalfunctionOct 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE ARTERIOVENOUS (AV) FISTULA. THE 5.00X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM). THEN THE BALLOON WAS INFLATED A SECOND TIME TO 20 (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED FROM THE PATIENT, WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SAME SIZE ARMADA BALLOON WAS TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592078 ↗