Armada 1013470-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08717648208447), received between Dec 14, 2016 and Nov 18, 2025 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (21 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THEN, A 6X40MM ARMADA 18 BDC WAS ADVANCE TO THE TARGET LESION AND THE BALLOON WAS INFLATED. HOWEVER, THE SECOND ARMADA BALLOON ALSO RUPTURED AT 10 ATM DURING THE FIRST INFLATION. THEREFORE, THE SECOND ARMADA BALLOON WAS REMOVED FROM THE PATIENT. ANOTHER 6X40MM ARMADA BALLOON WAS USED TO COMPLETE 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 23586378 ↗
• MalfunctionJul 1, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 6.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS BEING PREPPED WITH CONTRAST. HOWEVER, THE CATHETER WOULD NOT DRAW NEGATIVE. THE BALLOON WAS INFLATED AND NOTED TO HAVE A SMALL HOLE, CONTRAST WAS SEEN COMING OUT FROM THE HOLE. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ARMADA. THERE WAS NO PATIENT INVOLVEMENT 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 22376631 ↗
• MalfunctionJul 23, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC), NEGATIVE PRESSURE COULD NOT BE PULLED. THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811405 ↗
• MalfunctionSep 5, 2023Failure to Fold; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Fold; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 6.0X150MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONE TIME TO 12 ATMOSPHERES AND CONFIRMED TO BE FULLY DEFLATED BEFORE REMOVAL. HOWEVER, DURING REMOVAL THE BDC BECAME STUCK IN THE 6FR SHEATH AND A PORTION OF THE BDC BECAME SEPARATED. AS THE BALLOON WAS STILL ON THE GUIDE WIRE, THE ENTIRE BDC INCLUDING THE SEPARATED PORTION WERE REMOVED WITH THE GUIDE WIRE AND THE SHEATH AS A SINGLE UNIT. AFTER REMOVAL, THE BALLOON WAS NOTED TO BE HALFWAY INSIDE THE SHEATH AND BUNCHED. IT WAS FURTHER REPORTED THAT THE CONTRAST RATION USED WAS 30/70. 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 17686100 ↗
• MalfunctionJun 30, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 6.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED THE TARGET LESION WITH RESISTANCE DUE TO THE CALCIFIED ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 14 ATMOSPHERES. THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. A NON-ABBOTT BDC WAS USED TO COMPLETE 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 17239928 ↗
• MalfunctionMar 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 6.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION. THE BALLOON WAS INFLATED TO 14 ATMOSPHERES (ATMS) WHEN IT RUPTURED. THERE WAS NO RESISTANCE NOTED WHEN REMOVING THE BDC. ANOTHER SAME SIZE ARMADA 18 WAS USED TO CONTINUE 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 16486883 ↗
• MalfunctionDec 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT, PRIOR TO USE, THE ARMADA BALLOON DILATATION CATHETER (BDC) WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE BDC WAS ADVANCED TO THE TARGET LESION AND WAS INFLATED TWICE TO 14 ATMOSPHERES (ATM). DURING THE THIRD INFLATION, THE BALLOON RUPTURED AT 10 ATM. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PROCEDURE WAS COMPLETED WITH AN ARMADA 35 BALLOON CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946580 ↗
• MalfunctionOct 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.5X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND INFLATED TWICE AT 8 ATMOSPHERES (ATMS) AND 12 ATMS BUT RUPTURED DURING THE SECOND INFLATION. ANOTHER 6X150MM ARMADA 18 BDC WAS USED TO TREAT THE SFA. HOWEVER, THE SAME ARMADA 18 BDC WAS USED TO TREAT ANOTHER LESION IN THE POPLITEAL ARTERY WITH HEAVY CALCIFICATION AND RUPTURED AT 8 ATMS DURING THE FIRST INFLATION. THERE WAS NO RESISTANCE DURING ADVANCEMENT. ANOTHER ARMADA 18 BDC WAS USED TO TREAT THE POPLITEAL ARTERY AND COMPLETED THE PROCEDURE. ALL DEVICES WERE PREPPED AND USED PER THE INSTRUCTIONS FOR USE (IFU). 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 15679756 ↗
• MalfunctionOct 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS DISTAL RIGHT SUPERIOR FEMORAL ARTERY. THE 6.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 14 ATMOSPHERES DURING THE SECOND INFLATION. A NON-ABBOTT HIGH PRESSURE BALLOON WAS USED TO SUCCESSFULLY 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 15670393 ↗
• MalfunctionAug 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED TOTAL OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WAS PERFORMED. AN ARMADA 18 BALLOON WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 8 ATMOSPHERES WHEN IT RUPTURED. THEN A SECOND ARMADA 18 BALLOON WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 10 ATMOSPHERES WHEN IT RUPTURED. THERE WAS NO RESISTANCE NOTED AT ANY POINT. ANOTHER ARMADA BALLOON WAS USED TO SUCCESSFULLY 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 15212117 ↗
• MalfunctionAug 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED TOTAL OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WAS PERFORMED. AN ARMADA 18 BALLOON WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 8 ATMOSPHERES WHEN IT RUPTURED. THEN A SECOND ARMADA 18 BALLOON WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 10 ATMOSPHERES WHEN IT RUPTURED. THERE WAS NO RESISTANCE NOTED AT ANY POINT. ANOTHER ARMADA BALLOON WAS USED TO SUCCESSFULLY 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 15212033 ↗
• MalfunctionDec 20, 2021Material Rupture; Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043324 ↗
• MalfunctionNov 8, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770986 ↗
• MalfunctionOct 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0 X 150 MM ARMADA DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY. ON THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THE 6.0 X 180 MM ARMADA DILATATION CATHETER WAS THEN ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY; HOWEVER, ON THE FIRST INFLATION, THIS DEVICE ALSO RUPTURED AT 8 ATM. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12564068 ↗
• MalfunctionJul 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE ARMADA 18 6X100 MM PERCUTANEOUS TRANSLUMNIAL ANGIOPLASTY (PTA) CATHETER RUPTURED AFTER ONE INFLATION TO NOMINAL PRESSURE. THE DEVICE WAS REMOVED AND A NEW ARMADA 18 6X150 MM PTA CATHETER WAS USED AND AGAIN THE BALLOON RUPTURED AFTER ONE INFLATION AT NOMINAL PRESSURE. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 12111719 ↗
• MalfunctionApr 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 6X150MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUE, AND AN UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY 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 11738466 ↗
• InjuryApr 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE LEFT MID SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION. A 6X150MM ARMADA 18 BALLOON WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUES. AT THE START OF THE FIRST INFLATION AT 9 ATMOSPHERES, A LEAK WAS OBSERVED VIA FLUOROSCOPY. THE BALLOON WAS INFLATED A TINY BIT MORE, BUT THE BALLOON CONTINUED LEAKING AND BLOOD WAS OBSERVED IN THE CATHETER. THE BALLOON HAD RUPTURED AND CAUSED THE ARTERY TO PERFORATE. THIS RESULTED IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE ARMADA BALLOON WAS REMOVED. THE PERFORATION AND TARGET LESION WERE TREATED WITH ANOTHER ARMADA BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 11729128 ↗
• MalfunctionApr 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X150MM OTW ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITHOUT ISSUE. FIVE ADDITIONAL NON-ABBOTT BALLOONS WERE USED HOWEVER ALSO RUPTURED. THE PROCEDURE WAS COMPLETED USING A SUPERA STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613505 ↗
• MalfunctionMar 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. TWO 6X150MM ARMADA 18 BALLOONS RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ARTHRECTOMY AND AN ADDITIONAL UNSPECIFIED BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876041 ↗
• MalfunctionMar 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. TWO 6X150MM ARMADA 18 BALLOONS RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ARTHRECTOMY AND AN ADDITIONAL UNSPECIFIED BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876034 ↗
• MalfunctionNov 11, 2019Failure to Fold; Inflation Problem; Difficult to Remove; Failure to Fold; Inflation Problem; Difficult to Remove

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: RETURNED DEVICE ANALYSIS IDENTIFIED A SEPARATION IN THE OUTER MEMBER, BUT THIS WAS NOT NOTED DURING THE PROCEDURE. THE DEVICE LIKELY SEPARATED DURING RETURN PACKAGING OR SHIPMENT. IT WAS CONFIRMED THAT NO PORTION OF THE DEVICE REMAINS IN THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305061 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION, TREATING THE SUPERFICIAL FEMORAL ARTERY (SFA), MODERATELY CALCIFIED LESION. ATHERECTOMY WAS PERFORMED ON THE SFA. FOLLOWING, AN ARMADA DILATATION CATHETER WAS INFLATED TO 12 ATMOSPHERES (ATMS) FOR THE FIRST TIME AND BURST. A SECOND ARMADA DILATATION CATHETER WAS USED IN REPLACEMENT, HOWEVER THIS BALLOON WAS INFLATED TO 10ATMS THE FIRST TIME AND BURST. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714520 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION, TREATING THE SUPERFICIAL FEMORAL ARTERY (SFA), MODERATELY CALCIFIED LESION. ATHERECTOMY WAS PERFORMED ON THE SFA. FOLLOWING, AN ARMADA DILATATION CATHETER WAS INFLATED TO 12 ATMOSPHERES (ATMS) FOR THE FIRST TIME AND BURST. A SECOND ARMADA DILATATION CATHETER WAS USED IN REPLACEMENT, HOWEVER, THIS BALLOON WAS INFLATED TO 10ATMS THE FIRST TIME AND BURST. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714518 ↗
• MalfunctionDec 21, 2018Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL TO TIBIAL ARTERY WITH MODERATE CALCIFICATION. A 6.0 X 150 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED WITH NO RESISTANCE; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION TO 16 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL UNSPECIFIED BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191844 ↗
• MalfunctionAug 3, 2018Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 6.0 X 150 ARMADA 18 DILATATION CATHETER BALLOON WAS PREPARED FOR USE. NEGATIVE PRESSURE WAS PULLED AND AIR WAS NOTED; HOWEVER, THE DEVICE WAS USED IN THE PATIENT ANATOMY. WHILE IN THE PATIENT ANATOMY, NEGATIVE PRESSURE WAS PULLED AND AIR WAS NOTED. THE DEVICE WAS REMOVED WITHOUT RESISTANCE AND THERE WAS NO ADVERSE PATIENT EFFECT. IT WAS SUSPECTED THAT THE BALLOON WAS PERFORATED. A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7749479 ↗