Armada B1080-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 08717648154867), received between Sep 1, 2016 and May 29, 2026 — classified as 19 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (56 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS COMMON ILIAC ARTERY THAT IS 100% STENOSED. THE LESION WAS ACCESSED VIA IPSILATERAL FEMORAL APPROACH WITH A 6 FR SHEATH. A 0.035 NON-ABBOTT GUIDE WIRE WAS INSERTED, AND THE LESION WAS DILATED WITH AN UNSPECIFIED 4.0MM BALLOON. THE 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS USED FOR ADDITIONAL DILATATION; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. AN 8.X40MM NON-ABBOTT BALLOON AND 10MM NON-ABBOTT BALLOON WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334619 ↗
• MalfunctionApr 3, 2026Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT CEPHALIC VEIN. THE 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 13 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. 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 24777827 ↗
• MalfunctionFeb 12, 2026Leak/Splash

  IT WAS REPORTED THAT IN A VASCULAR ACCESS INTERVENTIONAL THERAPY (VAIVT) PROCEDURE TO TREAT AN 100% STENOSED LESION IN THE CEPHALIC VEIN WITH MODERATE CALCIFICATION. THE 8X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED ON A .018 NON-ABBOTT GUIDE WIRE (GW) VIA A 7FR SHEATH. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES (ATM); HOWEVER, PRESSURE WAS LOST WITH NO BALLOON RUPTURE, AND A CONTRAST LEAK WAS NOTED AT THE JUNCTION BETWEEN THE SHAFT AND THE STRAIN RELIEF OF THE BDC. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER ARMADA BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS ADVERSE PATIENT EFFECT REPORTED, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329339 ↗
• MalfunctionDec 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 8X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION BUT RUPTURED DURING INFLATION. 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 23811570 ↗
• MalfunctionDec 9, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE ILIAC ARTERY. THE 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING INFLATION, THE BALLOON CAUGHT ON THE PREVIOUSLY IMPLANTED STENT AND RUPTURED. THE BDC WAS REMOVED AND THE PROCEDURE COMPLETED USING A NON-ABBOTT DEVICE. 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 23756515 ↗
• MalfunctionSep 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS ARTERIOVENOUS ANASTOMOSIS THAT IS 80% STENOSED. AN 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A NEW 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 23090527 ↗
• InjurySep 10, 2025Entrapment of Device; Material Rupture; Material Separation; Difficult to Advance; Material Split, Cut or Torn; Entrapment of Device; Material Rupture; Material Separation; Difficult to Advance; Material Split, Cut or Torn

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT THE 8X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE DUE TO THE ANATOMY AND BY PIERCED ON THE ARTERY CALCIFICATION WAS REPORTING THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT AN UNKNOWN PRESSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022634 ↗
• MalfunctionJun 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE RIGHT EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. A NON-ABBOTT STENT WAS IMPLANTED. FOR POST-DILATATION, THE 8X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT APPROXIMATELY 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PHYSICIAN STATED THE RUPTURE WAS POSSIBLY DUE TO THE PREVIOUSLY IMPLANTED STENT. A NON-ABBOTT 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 22331137 ↗
• InjuryJun 17, 2025Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE ILIAC ARTERY. THE 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES. AN ATTEMPT WAS MADE TO RETRACT THE BALLOON CATHETER HOWEVER IT COULD NOT BE WITHDRAWN THROUGH THE SHEATH, ATTEMPTING TO DO SO RESULTED IN THE BALLOON AND THE SHEATH AND THE WIRE BECOMING LOCKED AS A SINGLE UNIT. AT THIS POINT FURTHER TENSION RESULTED IN THE DISTAL PART OF THE BALLON SEPARATING FROM THE DELIVERY SHAFT HOWEVER THIS ALLOWED REMOVAL OF THE DELIVERY CATHETER AND PROXIMAL PART OF THE BALLOON. THE DISTAL BALLOON MARKER WAS STILL VISIBLE ON THE WIRE CONFIRMING ITS LOCATION; THEREFORE THE TIP OF THE WIRE WAS SNARED FROM THE RIGHT GROIN AND WITHDRAWN FROM AN 8FR SHEATH AT THE RIGHT GROIN AND THE BALLOON WAS PUSHED FROM THE LEFT AND PULLED FROM THE RIGHT AND EXTRACTED. ANOTHER 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 22226812 ↗
• MalfunctionFeb 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. AN UNSPECIFIED GUIDEWIRE WAS PLACED AND AN 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS TRAVERSED; HOWEVER, RESISTANCE WITH ANATOMY WAS FELT. ONCE AT THE LESION THE ARMADA BALLOON RUPTURED DURING THE SECOND INFLATION AT NOMINAL PRESSURE AS IT WAS NOTED THE LESION WAS TIGHTER THAN EXPECTED. AN UNSPECIFIED DRUG COATED BALLOON (DCB) 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 21360324 ↗
• InjuryJan 28, 2025Deflation Problem; Difficult to Remove; Material Rupture; Material Separation; Deflation Problem; Difficult to Remove; Material Rupture; Material Separation

  SUBSEQUENTLY, AFTER THE PREVIOUS REPORT WAS FILED IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED COMMON LEFT ILIAC ARTERY. IT WAS CONFIRMED THAT THE DISTAL MARKER DID SEPARATE FROM THE ARMADA 35 AND WAS FOUND IN THE SUBCUTANEOUS TISSUE IN THE EXTRAVASCULAR AFTER ARTERIOGRAPHY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21256433 ↗
• MalfunctionNov 27, 2024Material Rupture; Insufficient Device Problem Information; Material Rupture; Insufficient Device Problem Information

  THE 8X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS RETURNED FOR ANALYSIS WITH ANOTHER REPORTED DEVICE. THE DEVICE ANALYSIS NOTED A RUPTURE ON THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798796 ↗
• MalfunctionOct 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE COMMON ILIAC ARTERY (CIA) WITH 75% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT BUT RUPTURED DURING THE FIRST INFLATION TO 15 ATMOSPHERES (ATMS). A NON-ABBOTT BALLOON WAS USED TO CONTINUE AND 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 20499013 ↗
• InjuryOct 15, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, IT WAS REPORTED THE DISTAL MARKER SEPARATED INSIDE THE ANATOMY AND WAS RETRIEVED USING A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455726 ↗
• InjurySep 30, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT COMMON ILIAC ARTERY. A 8X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED WHEN INFLATING TO 8 ATMOSPHERES (ATM). WHEN WITHDRAWING THE BDC, THE BALLOON GOT CAUGHT AT THE TIP OF THE INTRODUCER SHEATH AND SEPARATED FROM THE BALLOON CATHETER BUT REMAINED ON THE GUIDEWIRE. THE SHEATH WAS REMOVED AND THE SURGEON CUT DOWN TO REMOVE THE BALLOON FROM THE VESSEL AND REMOVE IT OFF THE GUIDEWIRE. THE ARTERY WAS CLOSED AND A NON-ABBOTT DEVICE WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 20335644 ↗
• MalfunctionJun 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE COMMON ILIAC ARTERY. A 12MM×40MM NON-ABBOTT STENT WAS DEPLOYED TO TREAT THE LESION AND POST DILATION WAS ATTEMPTED USING A 8.0MM×40MM ARMADA 35 BALLOON DILATATION CATHETER; HOWEVER THE BALLOON RUPTURED AT APPROXIMATELY 2-3 ATMOSPHERES. THE ARMADA WAS REPLACED WITH A NON-ABBOTT DEVICE AND THE PROCEDURE WAS COMPLETED. 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 19588231 ↗
• InjuryMar 7, 2024Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 8X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS USED AND AFTER DEFLATING THE BALLOON, IT WAS ATTEMPTED TO PULL OUT THE BALLOON FROM THE SHEATH BUT THERE WAS RESISTANCE AND THE BALLOON RIPPED. ANGIOGRAPHY WAS PERFORMED BUT THE PIECE OF BALLOON WAS NOT SEEN. THERE WAS NO ADVERSE PATIENT SEQUELA AND BLOOD FLOW IS PROPER IN ALL VESSELS; HOWEVER, THERE IS THE POTENTIAL THE MATERIAL REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 18856935 ↗
• MalfunctionFeb 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT INTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 75% STENOSIS. THE ARMADA 35 8MM/40MM ON 80CM BALLOON DILATATION CATHETER WAS USED, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 10 ATMOSPHERES AFTER 30 SECONDS INFLATION. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN THOUGHT THAT THE HEAVY CALCIFICATION WAS THE CAUSE FOR THE RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763584 ↗
• MalfunctionDec 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS RIGHT EXTERNAL LILAC ARTERY. THE 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS INFLATED FOR 30 SECONDS; HOWEVER, RUPTURED AT 14 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DLEAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268733 ↗
• InjuryNov 6, 2023Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON FEMORAL ARTERY (CFA) WITH 91% STENOSIS, HEAVY CALCIFICATION AND NO TORTUOSITY. THE 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH SLIGHT RESISTANCE WITH THE ANATOMY AND RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATMS). UPON REMOVAL, THE BALLOON GOT STUCK ON THE GUIDE WIRE AND EXCESSIVE FORCE WAS APPLIED REMOVING THE GUIDE WIRE AND BDC AS A SINGLE UNIT. ENLARGEMENT OF THE ACCESS SITE AND HEMORRHAGE WERE NOTED AND WAS TREATED BY MANUAL COMPRESSION. HEMOSTASIS WAS OBTAINED AFTER 15 MINUTES AND THERE WAS A DELAY IN THE PROCEDURE OF 30 MINUTES. THE PATIENT IS UNDER OBSERVATION AND WILL HAVE ANOTHER OPERATION IN ORDER TO TREAT THE INITIAL LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 18078667 ↗
• InjurySep 18, 2023Failure to Fold; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Failure to Fold; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN IN-STENT RESTENOSIS LESION IN THE EXTERNAL ILIAC ARTERY WITH MODERATE CALCIFICATION AND 50% STENOSIS. THE 8X40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE FOR FIVE SECONDS AND A RUPTURE OCCURRED BELOW NOMINAL PRESSURE. AFTER THE RUPTURE, THE MARKERS WERE NOTED FURTHER AWAY THAN 40MM APART FROM EACH OTHER. THERE WAS A LOT OF DIFFICULTY DURING REMOVAL AS THE BALLOON DID NOT WRAP BACK UP [FOLD]; THEREFORE, THE TIP OF THE SHEATH WAS U-SHAPED, SLIGHTLY KINKED AND THE ENTRY OF THE DISTAL TIP WAS VERY DENTED MAKING THE REMOVAL HARDER. THE SHEATH TOP WAS NOTED DAMAGED AFTER FORCEFUL REMOVAL AND THE MARKERS WERE TAKEN OUT THROUGH THE SHEATH AS THEY SEPARATED FROM EACH OTHER. THERE WAS A POSSIBLE THROMBUS AT THE RUPTURE SITE AND ASPIRATION WAS PERFORMED, CONFIRMING THE THROMBUS. AS TREATMENT, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED, NO PERIPHERAL EMBOLISMS WERE FOUND. THERE WAS A DELAY IN THE PROCEDURE AND MORE RADIATION EXPOSURE; HOWEVER, THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17769404 ↗
• MalfunctionAug 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS NON-TORTUOUS. THE ARMADA 35 BALLOON RUPTURED WHEN INFLATED ABOVE NOMINAL PRESSURE (EXACT PRESSURE UNKNOWN). A NON-ABBOTT BALLOON WAS USED AS THE REPLACEMENT DEVICE. 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 17455087 ↗
• InjuryApr 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH A 35 ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER; HOWEVER, A RUPTURED OCCURRED DURING INFLATION; THEREFORE, A SNARE DEVICE WAS USED TO RETRIEVE THE BALLOON. THERE WERE NO ADVERSE PATIENT SEQUELA 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 16809055 ↗
• MalfunctionNov 4, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT COMMON ILIAC ARTERY WITH MILD CALCIFICATION AND NO TORTUOSITY. THE ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 14 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. THE DEVICE WAS NOT PREPARED (AIR ASPIRATION) OUTSIDE OF THE BODY PRIOR TO USE. 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 15736320 ↗
• MalfunctionSep 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 90% LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. ATHERECTOMY WAS PERFORMED AND AN 8X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME; HOWEVER, IT RUPTURED AT BURST PRESSURE. SUBSEQUENTLY, AN 8X60MM ARMADA 35 BDC WAS ADVANCED AND INFLATED ONE TIME TO NOMINAL PRESSURE WHEN THE BALLOON RUPTURED AND SEPARATED FROM THE CATHETER IN THE RIGHT EXTERNAL ILIAC ARTERY. ONE HOUR WAS SPENT TRYING TO SNARE OUT THE SEPARATED SEGMENT, HOWEVER IT WAS UNSUCCESSFUL. AN 8.X5CM NON-ABBOTT COVERED STENT WAS IMPLANTED TO EMBED THE SEPARATED SEGMENT IN THE ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499392 ↗