Armada 1013470-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08717648208461), received between Oct 12, 2016 and Jun 30, 2025 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 018 COMMAND ST GUIDE WIRE (GW) WAS ADVANCED THROUGH A 6FFSHEATH VIA LEFT GROIN ACCESS, UP AND OVER INTO RIGHT LEG. DURING ADVANCEMENT, RESISTANCE WAS NOTED THROUGHOUT THE WHOLE VESSEL DUE TO CALCIUM. THE VESSEL WAS PRE-TREATED TWICE WITH LASER ATHERECTOMY. FOLLOWING THIS, A 6.0X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE AND INFLATED IT TO 14 ATMS, FIVE TIMES, FOR 20 SECONDS EACH TIME. THE DECISION WAS MADE TO RE-TREAT THE LESION WITH THE LASER ATHERECTOMY. THE ARMADA 18 BDC WAS REMOVED, AND THE LASER ATHERECTOMY WAS PERFORMED. THE ARMADA 18 BDC WAS REINSERTED BACK INTO THE LESION AND INFLATED 9 TIMES AT 14 ATMS FOR 20 SECONDS; HOWEVER, THE BALLOON RUPTURED. THE BDC WAS REMOVED AND A 7X120MM ARMADA 35 BDC WAS ADVANCED WITH RESISTANCE DUE TO CALCIUM AND POSITIONED MORE PROXIMAL IN THE SFA. THE ARMADA 35 WAS INFLATED FOR 30 SECONDS AT 10 ATMS, THEN INFLATED AGAIN TO 10 ATMS FOR 10 SECONDS; HOWEVER, THE BALLOON RUPTURED ON THE SECOND INFLATION. THE BDC WAS REMOVED, AND TWO MORE PASSES WERE PERFORMED WITH THE LASER ATHERECTOMY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365430 ↗
• MalfunctionNov 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X200 ARMADA 018 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION TO NOMINAL PRESSURE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER DIFFERENT SIZE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623970 ↗
• MalfunctionOct 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUPERIOR FEMORAL ARTERY THAT IS 100% STENOSED. THE LESION WAS LASERED DUE TO THE TOTAL OCCLUSION. THE 6.0X200MM ARMADA 18 BALLOON WAS ADVANCED ALONG WITH A 6FSHEATH. THE ARMADA BALLOON WAS INFLATED TO 12 ATMOSPHERES FOR THE FIRST AND SECOND INFLATION. THE ARMADA WAS REMOVED FROM THE ANATOMY AND LESION WAS CHECKED VIA ANGIOGRAPHY. THE BALLOON WAS RE-INSERTED AND INFLATED FOR THIRD TIME TO 10 ATMOSPHERES WHEN THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED STENT. 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 20523849 ↗
• MalfunctionJun 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 6X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 4 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. THE PROCEDURE WAS CONTINUED WITH ANOTHER ARMADA BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449359 ↗
• MalfunctionFeb 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 6 ATMOSPHERES (ATMS). 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 18793438 ↗
• MalfunctionOct 9, 2023Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL ARTERY THAT WAS MODERATELY CALCIFIED. THE 6.0X200MM ARMADA 18 OTW BALLOON CATHETER WAS INFLATED TO 8 ATMOSPHERES; HOWEVER, THE BALLOON WOULD NOT DEFLATE FULLY AND BECAME STUCK IN THE INTRODUCER SHEATH DURING REMOVAL. THE BALLOON CATHETER AND INTRODUCER SHEATH HAD TO BE REMOVED AS A UNIT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS NOTED THAT THE CONTRAST WAS 70 SALINE TO 30 CONTRAST. 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 17896829 ↗
• MalfunctionAug 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RESTENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X200MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE AND A RUPTURE OCCURRED AT 14 ATMOSPHERES. ANOTHER ARMADA 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 17439196 ↗
• MalfunctionMay 10, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. THE 6.00X200MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH SOME RESISTANCE DUE TO THE CALCIFICATION. THE BALLOON RUPTURED DURING FIRST INFLATION AT 10 ATMOSPHERE (ATM). THE BDC WAS REMOVED WITHOUT ISSUE AND REPLACED WITH ANOTHER ARMADA BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906111 ↗
• MalfunctionMar 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED FEMORAL ARTERY. THE 6.0X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 7 ATMOSPHERES AND THEN INFLATED FOR A SECOND TIME TO 8 ATMOSPHERES WHEN THE BALLOON RUPTURED. ANOTHER SAME SIZE ARMADA 18 BDC WAS USED TO SUCCESSFULLY 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 16573099 ↗
• MalfunctionJun 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO ISSUE. DURING THE FIRST INFLATION TO 4 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED WITH ANOTHER ARMADA 18. 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 14855476 ↗
• MalfunctionJun 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6X200MM ARMADA 18 BALLOON WAS INFLATED ONCE AND RUPTURED AT 6 ATMOSPHERES. ANOTHER ARMADA 18 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 12088480 ↗
• MalfunctionApr 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6X200MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES. A SAME SIZED 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 11721613 ↗
• MalfunctionApr 15, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE ARMADA 18 BALLOON CATHETER WAS WIPED DOWN BUT THE BALLOON WAS NOT SOAKED AS INSTRUCTED IN THE IFU. AFTER THE DEVICE WAS ADVANCED TO THE UNSPECIFIED LESION, THE ARMADA 18 BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE SECOND INFLATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673661 ↗
• MalfunctionApr 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE 6.0MM X 200MM X 150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON RUPTURED. IT IS UNKNOWN AT WHAT ATMOSPHERES OR DURING WHICH INFLATION THE RUPTURE OCCURRED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11625523 ↗
• MalfunctionJan 13, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 6.0X200MM ARMADA 18 BALLOON DILATATION CATHETER WAS POSITIONED WITH RESISTANCE DURING ADVANCEMENT DUE TO THE ANATOMY. DURING INFLATION, THE BALLOON RUPTURED AT 10ATM ON THE FIRST INFLATION. THE BALLOON CATHETER WAS REMOVED WITHOUT ISSUE AND REPLACED WITH A NEW ARMADA 18 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 Consequences Or Impact To Patient

  MAUDE report 11166818 ↗
• MalfunctionJun 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, NON-TORTUOUS, 70% STENOSED SUPERFICIAL FEMORAL ARTERY. A 6X200MM, 3X80MM, & 5.5X200MM ARMADA 18 AS WELL AS A 3X40MM & 4X60MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETERS (PTA) WERE ALL ADVANCED, AND THE BALLOONS RUPTURED AT 14 ATMOSPHERES IN THAT ORDER. A NON-ABBOTT BALLOON AND TWO UNSPECIFIED STENTS WERE 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 Consequences Or Impact To Patient

  MAUDE report 10154016 ↗
• MalfunctionMay 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0X200 MM ARMADA 18 BALLOON DILATATION CATHETER WAS PROPERLY PREPARED OUTSIDE THE PATIENT WITHOUT ISSUE. THE ARMADA 18 WAS ADVANCED TO THE LEFT SUPERFICIAL FEMORAL ARTERY AND INFLATED TO TEN ATMOSPHERES, BUT THE ARMADA RUPTURED WITH THE FIRST INFLATION. THE ARMADA WAS REMOVED IN ONE PIECE WITHOUT RESISTANCE. A SAME SIZE NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10065262 ↗
• MalfunctionFeb 26, 2020Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  ADDITIONAL INFORMATION REPORTED THAT IT WAS THE DISTAL SHAFT WITH THE BALLOON THAT SEPARATED AND NOT JUST THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9758322 ↗
• MalfunctionSep 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WAS PERFORMED, AND THE 6 X 200 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE. THE PTA INFLATED ONCE AT SIX ATMOSPHERES WHEN IT RUPTURED. AN UNSPECIFIED ARMADA 18 PTA 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 Consequences Or Impact To Patient

  MAUDE report 9104491 ↗
• MalfunctionSep 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200 MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. THE BALLOON RUPTURED AT 8 ATMOSPHERES ON THE FIRST INFLATION. THE BDC WAS REMOVED AND REPLACED WITH A NEW NON-ABBOTT DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8983436 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION (PCI) TREATING A SUPERFICIAL FEMORAL ARTERY (SFA), MODERATELY CALCIFIED LESION. FOLLOWING ATHERECTOMY, THE ARMADA DILATATION CATHETER BALLOON BURST AT THE FIRST INFLATION, AT 10 ATMOSPHERES. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PROCEDURE CONTINUED WITH GOOD OUTCOMES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714548 ↗
• MalfunctionMay 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. DURING THE FIRST INFLATION, THE 6.0 X 200 ARMADA 18 DILATATION CATHETER BALLOON RUPTURED AT 10 ATMOSPHERES. THERE WAS NO DIFFICULTY NOTED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE, AND ALL PORTIONS OF THE DEVICE WERE REMOVED. 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 8601271 ↗
• MalfunctionSep 20, 2018Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 6.0X200MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (PTAC) WAS ADVANCED TO THE LESION WITHOUT ISSUE. THE BALLOON WAS THEN INFLATED ONCE AT 8 ATMOSPHERES; HOWEVER, THE BALLOON PARTIALLY INFLATED AND FLUOROSCOPY REVEALED THAT THE BALLOON WAS LEAKING. THE CATHETER WAS REMOVED WITHOUT ISSUE, AND ANOTHER SAME SIZE ARMADA 18 PTAC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7894548 ↗
• MalfunctionMay 21, 2018Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A PERIPHERAL PROCEDURE TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE 6.0 X 200 MM ARMADA 18 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION. THE DEVICE WAS INFLATED TO 8 ATMOSPHERES AND IT WAS NOTED THAT THE PRESSURE WENT DOWN DUE TO A TEAR IN THE BALLOON CAUSED BY VESSEL CALCIFICATION. THE ARMADA 18 WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT DIFFICULTY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. A SECOND NON-ABBOTT DILATATION CATHETER WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7530871 ↗
• MalfunctionMar 8, 2018Material Rupture

  IT WAS REPORTED THAT AN ARMADA DILATATION CATHETER ADVANCED TO THE SUPERFICIAL FEMORAL ARTERY, MODERATELY CALCIFIED LESION. BALLOON INFLATION WAS PERFORMED AT 4 ATMOSPHERES (ATMS), WHEN THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324960 ↗