Armada B1070-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08717648154805), received between Aug 23, 2016 and Apr 9, 2026 — classified as 10 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (25 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 70% STENOSED. ONCE AT THE LESION, THE 7.0X80MM ARMADA 35 BALLOON DILATATION CATHETER WAS INFLATED THREE TIMES TO 10 ATMOSPHERES WHEN CONTRAST AGENT LEAKAGE WAS NOTED. THE ARMADA 35 BALLOON WAS WITHDRAWN AND A NEW 7.0X80MM ARMADA 35 BDC WAS USED TO COMPLETE THE PROCEDURE.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 24832241 ↗
• MalfunctionFeb 25, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RESTENOSIS, HEAVILY CALCIFIED, HEAVILY TORTUOUS ARTERIOVENOUS FISTULA LESION WITH 80% STENOSIS. A 7X80 MM ARMADA 35 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 THE FIRST INFLATION AT 12 ATM, THE BALLOON RUPTURED. AN ADDITIONAL 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 24448851 ↗
• MalfunctionJan 16, 2026Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, AND 80% STENOSED COMMON FEMORAL ARTERY. AN ARMADA 35 7MM/80MM WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, DURING THE FIRST INFLATION, A BALLOON RUPTURE OCCURRED AT 12ATM. THEREFORE, THE DEVICE WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED WITH ANOTHER ARMADA 35. 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 24100326 ↗
• MalfunctionNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN ARTERIOVENOUS FISTULA IN THE RESTENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS CEPHALIC VEIN THAT IS 80% STENOSED. THE 7.0X80MM 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 23662854 ↗
• MalfunctionNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RADIAL ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 80% STENOSIS. THE 7X80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 10 ATMOSPHERES AND RUPTURED. ANOTHER UNSPECIFIED CATHETER 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 23596566 ↗
• MalfunctionNov 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS CEPHALIC VEIN THAT IS 80% STENOSED. THE 7X80MM ARMADA 35 BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE SECOND INFLATION. ANOTHER ARMADA 35 BALLOON 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 23498073 ↗
• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE ARTERIOVENOUS (AV) ANASTOMOSIS WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 7 X 80 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER ARMADA BDC 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 23452443 ↗
• MalfunctionSep 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS COMMON FEMORAL ARTERY THAT IS 80% STENOSED. ONCE AT THE LESION, THE 7.0X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), RUPTURED AT 14 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED CATHETER 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 23156732 ↗
• MalfunctionJul 28, 2025Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED LEFT CEPHALIC VEIN. THE 7.0X80MM ARMADA 35 PTA BALLOON DILATATION CATHETER, THAT WAS TO BE USED FOR THROMBECTOMY, RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. A NON-ABBOTT 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 22639470 ↗
• InjuryNov 7, 2024Entrapment of Device; Material Rupture; Material Separation; Difficult to Advance; Entrapment of Device; Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ACCESSORY VEIN. THE 7X80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION WITH DIFFICULTY NOTED WITH THE ANATOMY. THE BALLOON RUPTURED AND SEPARATED DURING FIRST INFLATION AT 16 ATMOSPHERES (ATM). A SNARE WAS USED TO REMOVE THE DEVICE AS IT WAS STUCK ON THE NON-ABBOTT GUIDE WIRE. ANOTHER ARMADA 35 PTA CATHETER WAS USED, BUT IT FAILED TO OPEN THE LESION DESPITE THERE BEING NO ISSUES WITH THE DEVICE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632243 ↗
• MalfunctionSep 17, 2024Material 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 AV FISTUAL WITH HEAVY CALCIFICATION. THE 7.0X80MM ARMADA 35 BALLOON CATHETER COULD NOT HOLD PRESSURE AT 16 ATMOSPHERES AND A RUPTURE WAS NOTED. A NEW ARMADA BALLOON 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 20237938 ↗
• MalfunctionSep 11, 2024Material Rupture; Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20194826 ↗
• MalfunctionAug 5, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY STENOSED LEFT SAPHENOUS VEIN GRAFT. DURING ADVANCEMENT OF THE 7.0X80MM ARMADA 35 BALLOON RESISTANCE WAS FELT WITH ANATOMY. ONCE AT THE LESION THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 15 ATMOSPHERES. ANOTHER SAME SIZE ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907116 ↗
• MalfunctionFeb 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN AN UNSPECIFIED ARTERY MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 7X80MM ARMADA 35 BALLOON DILATATION CATHETER WAS USED IN A PROCEDURE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). ANOTHER ARMADA 35 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 18655791 ↗
• MalfunctionNov 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LOWER EXTREMITY. FOUR BALLOON DILATATION CATHETERS (BDCS), 7.0X80MM ARMADA 35, 6.0X80MM ARMADA 35, AND TWO 3.0X60MM ARMADA 18, WERE INFLATED AT AN UNKNOWN PRESSURE BUT ALL BURST BEFORE REACHING NOMINAL PRESSURE. ANOTHER ABBOTT 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 18067463 ↗
• MalfunctionJun 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CEPHALIC ARTERY. REPORTEDLY, THE ARMADA 35 7MM/80MM BALLOON CATHETER RUPTURED DURING THE SECOND INFLATION AT 7 ATMOSPHERES. THE BALLOON WAS REMOVED WITHOUT ISSUE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052895 ↗
• MalfunctionOct 25, 2022Difficult to Remove; Device Contaminated During Manufacture or Shipping; Difficult to Remove; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE 7.0X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS OPENED AND NOTED TO HAVE A HAIR INSIDE THE PACKAGE. THE DEVICE WAS NOT USED. ANOTHER ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. PER DEVICE ANALYSIS THE PROTECTIVE SHEATH WAS FROZEN ON THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670329 ↗
• MalfunctionSep 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 60% STENOSED LESION IN THE ATRIOVENTRICULAR ( AV) FISTULA. A 7X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME TO 12 ATMOSPHERES (ATM) WHEN A RUPTURE OCCURRED. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503268 ↗
• InjuryNov 17, 2021Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE SEVERELY STENOSED LEFT BRACHIAL VEIN. THE 7.0 X 80 MM ARMADA 35 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION. THE BALLOON WAS INFLATED WITHOUT ISSUE; HOWEVER, IT COULD NOT BE DEFLATED. THE PHYSICIAN CONNECTED TWO DIFFERENT INDEFLATORS, BUT WAS UNABLE TO DEFLATE THE BALLOON. A 20 CC SYRINGE WAS THEN ATTACHED, BUT THE BALLOON COULD STILL NOT BE DEFLATED. THE PHYSICIAN THEN ADMINISTERED 3000 UNITS OF HEPARIN AND ADMINISTERED LIDOCAINE AT THE REGION. AN 18 GAUGE NEEDLE WAS THEN USED, THROUGH THE SKIN, TO PUNCTURE THE BALLOON. THE BALLOON WAS THEN ABLE TO DEFLATE AND WAS REMOVED. A SECOND ARMADA DILATATION CATHETER WAS THEN USED TO COMPLETE THE DILATATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND THE PATIENT WAS DOING WELL POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829917 ↗
• InjuryAug 17, 2021Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TIGHT LESION WITH SCARE TISSUE AND HEAVY TORTUOSITY IN THE RIGHT BRACHIAL VEIN. A 7.0 X 80 MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 22 ATMOSPHERES. WHEN THE BALLOON CATHETER WAS BEING REMOVED, THERE WAS RESISTANCE WITH THE ANATOMY AND THE DISTAL PORTION OF THE BALLOON SEPARATED. A SURGEON WAS CONSULTED, AND IT WAS DECIDED TO LEAVE THE SEPARATED BALLOON PORTION IN THE PATIENT ANATOMY AS IT WAS LODGED IN A SMALL BRANCH. THE PATIENT REMAINED STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12331154 ↗
• InjuryJul 1, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT SUPERA STENTS WERE IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WITHOUT ISSUE. A 7X80MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS THEN ADVANCED WITH AN UNSPECIFIED 6F SHEATH TO THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 95% STENOSED, DE NOVO COMMON FEMORAL ARTERY LESION. THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE ARMADA PTA CATHETER FELT RESISTANCE WITH THE SHEATH DURING REMOVAL, AND THE BALLOON SEPARATED IN THE SHEATH. THE SHEATH, PTA CATHETER, AND AN UNSPECIFIED GUIDE WIRE WERE REMOVED TOGETHER. WHILE ADVANCING ANOTHER UNSPECIFIED GUIDE WIRE AND SHEATH, WHAT APPEARED TO BE A PIECE OF THE BALLOON WAS NOTED TO BE CAUGHT IN THE SUPERA STENT. A NON-ABBOTT BALLOON WAS INFLATED AND A COVERED STENT WERE USED TO EMBED THE SEPARATED PORTION OF BALLOON AGAINST THE VESSEL WALL. THERE WERE NO ADVERSE SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12102059 ↗
• InjuryMay 17, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT COMMON AND SUPERFICIAL FEMORAL ARTERIES WITH CALCIFICATION. DURING THE PROCEDURE, THE 7.0X80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS BEING USED TO POST-DILATE A STENT. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES AND WHEN IT WAS ATTEMPTED TO INCREASE THE PRESSURE, THE BALLOON RUPTURED. RESISTANCE WAS NOTED DURING REMOVAL WITH THE SHEATH AND IT WAS TRIED TO PUSH THE BALLOON AND WITHDRAW IT TOGETHER WITH THE SHEATH. WHEN PULLED, A PORTION SEPARATED AND THE PATIENT HAD TO BE SENT TO SURGERY TO RETRIEVE THE SEPARATED PORTION OF THE BALLOON. THE PATIENT RECOVERED WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11838511 ↗
• InjuryFeb 10, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THROMBOSIS IN THE LEFT ARTERIOVENOUS (AV) FISTULA. AN ARMADA BALLOON CATHETER WAS INSERTED, AND ANGIOPLASTY WAS PERFORMED. HOWEVER, AFTER ANGIOPLASTY WAS PERFORMED, ANGIOGRAM SHOWED RESIDUAL THROMBUS AND AN ANEURYSM OF THE AV FISTULA. A HIGH-GRADE STENOSIS OF THE AV FISTULA WAS ALSO NOTED. DURING REMOVAL OF THE BALLOON CATHETER, THE PHYSICIAN STATED THAT DUE TO PATIENT ANATOMY, THE DEVICE WAS DIFFICULT TO REMOVE. THE BALLOON CATHETER WAS ABLE TO BE REMOVED WITHOUT CAUSING DAMAGE TO THE PATIENT. TO FURTHER TREAT THE STENOSED AREA, A NON-ABBOTT DEVICE WAS SUCCESSFULLY USED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 11308107 ↗
• InjuryDec 7, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORTS, A CUTDOWN PROCEDURE WAS PERFORMED TO REMOVE ALL DEVICE MATERIAL FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10963471 ↗
• MalfunctionJul 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ARTERIOVENOUS FISTULA (AVF). A 7X80MM ARMADA 35 BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BALLOON CATHETER WAS BEING USED TO DILATE THE LESION; HOWEVER, THE BALLOON RUPTURED AT 14 ATMOSPHERES (ATMS). THE BALLOON CATHETER DID NOT RESOLVE THE FISTULA STENOSIS DUE TO THE TIGHT STENOSIS. A 7X40MM ARMADA BALLOON CATHETER WAS INFLATED TO 15 ATMS TO TREAT THE WAIST AND A NON-ABBOTT STENT WAS DEPLOYED TO SUCCESSFULLY TREAT THE FISTULA STENOSIS. FINAL ANGIOGRAPHY SHOWED A WIDELY PATENT PROXIMAL AVF AND GOOD FLOW. 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 10298730 ↗