Armada B1120-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08717648154980), received between Sep 22, 2017 and Jun 9, 2026 — classified as 13 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (28 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 9, 2026Material Rupture

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "ARMADA PTA .035IN X 12MM X 40MM X 80CM INFLATED IN ILIAC VEIN RUPTURED WHILE INSERTED, POTENTIALLY DUE TO GETTING CAUGHT ON THE STENT, CAUSING DEFLATION OF BALLOON WHILE INSERTED IN VEIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448361 ↗
• MalfunctionJun 5, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED VEIN LESION. A 12X40 MM ARMADA 35 PTA BALLOON DILATION 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 WITHOUT ISSUE. HOWEVER, DURING THE FIRST INFLATION AT 4 ATM, THE BALLOON RUPTURED. AN ADDITIONAL 12X40 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 25410994 ↗
• InjuryJun 25, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT A HEAVILY CALCIFIED PREVIOUSLY STENTED COMMON FEMORAL ARTERY. A 12X40MM ARMADA 35 BALLOON RUPTURED AT 10 ATMOSPHERE AND THE END SEPARATED, REMAINING STUCK IN THE ANATOMY WITHOUT BEING ABLE TO REMOVE. THEREFORE, THE PATIENT WAS PUT UNDER GENERAL ANESTHESIA AND PERFORMED AN ARTERIAL APPROACH TO REMOVE THE MATERIAL AND SUTURE THE FEMORAL ARTERY. THERE WAS 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 22332535 ↗
• InjuryJun 24, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA IN THE INNOMINATE TRUNK. THE 12.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND USED FOR POST DILATATION OF AN OMNILINK STENT; HOWEVER THE BALLOON BECAME STUCK WITHIN THE STENT AND ON THE GUIDE WIRE AND SUBSEQUENTLY SEPARATED. THE SEPARATED PORTION WAS SURGICALLY REMOVED. ANOTHER BALLOON 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 22318011 ↗
• InjuryJun 19, 2025Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A COMMON ILIAC ARTERY. A NON-ABBOTT GUIDE WIRE AND GUIDE CATHETER WERE ADVANCED TO THE EXTERNAL ILIAC ARTERY ON THE RIGHT AND SIGNIFICANT STENOSIS WAS PRESENT IN THE COMMON FEMORAL ARTERY THEREFORE, THE WIRE WAS EXCHANGED TO A .018 COMMAND GUIDE WIRE. LASER ATHERECTOMY WAS PREFORMED 3 TIMES WITH ANGIO SHOWING SIGNIFICANT IMPROVEMENT FLOW. A 10X39MM OMNILINK ELITE STENT WAS ADVANCED OVER THE WIRE INTO THE DISTAL AORTA AND DEPLOYED; HOWEVER THE BALLOON ON THE DELIVERY SYSTEM RUPTURED AT 6 ATMOSPHERES NOT ALLOWING THE STENT TO FULLY EXPAND. A 12X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ATTEMPTED TO BE USED FOR POST DILATATION; HOWEVER, RUPTURED AT 6 ATMOSPHERES. (BDC). DURING REMOVAL RESISTANCE WAS FELT WHEN PULLING INTO THE SHEATH AND THE BDC SEPARATED IN HALF AND THE DISTAL MARKER STILL ON THE WIRE JUST OUTSIDE THE SHEATH. AN ATTEMPT WAS MADE TO PULL IN THE SEPARATED PORTION INTO THE SHEATH WHEN ASPIRATING; HOWEVER WAS UNSUCCESSFUL AS THE BALLOON CONTINUED TO GET STUCK ON THE ARTERIAL WALL. A HEMOSTAT WAS USED TO PULL THE SEPARATED PORTION OF THE BALLOON FROM THE ARTERIOTOMY ALL SEPARATED PORTIONS WERE REMOVED. A PERCLOSE WAS USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289610 ↗
• MalfunctionJun 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A SUBCLAVIAN VEIN STENOSIS. THE 12X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. 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 22131095 ↗
• InjuryMay 27, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSIS HEAVILY CALCIFIED, HEAVILY TORTUOUS ATRIOVENTRICULAR FISTULA THAT IS 80% STENOSED. DURING THE FIRST INFLATION OF A 12X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), A RUPTURE OCCURRED AT 6 ATMOSPHERES. DURING REMOVAL, THE TIP DID NOT MOVE AND WAS NOTED TO BE SEPARATED INSIDE THE PATIENT ANATOMY. A SNARE WAS USED TO REMOVE THE SEPARATED TIP. A NEW UNSPECIFIED ARMADA 35 BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089508 ↗
• MalfunctionFeb 20, 2025Unintended System Motion; Difficult to Advance; Unintended System Motion; Difficult to Advance

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE COMMON ILIAC ARTERY. AFTER A NON-ABBOTT GUIDEWIRE WAS USED TO CROSS THE LESION, A 12X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION; HOWEVER, IT WAS NOTED TO REPEATEDLY SLIP DURING INFLATION. THE ARAMDA BDC WAS REMOVED AND REPLACED WITH A 8X20MM BDC AND THE PROCEDURE WAS CONTINUED. HOWEVER, DURING AN ATTEMPT TO REINSERT THE ARAMDA 35 BDC IT WAS NOTED THAT THE BDC COULD NOT BE ADVANCED THROUGH THE 6F SHEATH. THEREFORE A NEW 12X20 ARMADA 35 BDC WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422714 ↗
• MalfunctionDec 16, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CORONARY ARTERY. WHEN ATTEMPTING TO CONNECT AN UNSPECIFIED INDEFLATOR TO A 12X40MM ARMADA 35 BALLOON DILATATION CATHETER A CRACK WAS NOTED AT THE HUB AND LEAKED. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20940997 ↗
• InjuryAug 26, 2024Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Scratched Material; Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Scratched Material

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE PULMONARY VALVE. A 12X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED; HOWEVER, THE BALLOON WAS NOTED TO RUPTURE AT 10ATM DURING THE FIRST INFLATION. A STRONG RESISTANCE WAS NOTED DURING REMOVAL THROUGH THE 7F GUIDING SHEATH, AND THE SHAFT OF THE BDC SEPARATED. THE PHYSICIAN DECIDED TO PERFORM SURGERY TO REMOVE THE SEPARATED SHAFT, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS PROVIDED. THE SHAFT WAS NOT SEPARATED, THE BALLOON SEPARATED. ADDITIONALLY THE CUTS NOTED TO THE BALLOON AND INNER MEMBER WERE DUE TO THE SURGICAL REMOVAL OF THE DEVICE. THE BALLOON WAS NOTED TO BE SCRATCHED WHEN ATTEMPTING TO REMOVE IT THROUGH THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065151 ↗
• MalfunctionJun 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT SUBCLAVIAN VEIN WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY AND 100% CHRONIC TOTAL OCCLUSION. THE 12X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED ON THE FIRST INFLATION TO 10 ATMOSPHERES DURING USE. 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 19625072 ↗
• MalfunctionJun 20, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 75% STENOSIS. THE 12X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE. THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT THE PRESSURE OF THE INDEFLATOR DID NOT INCREASE SO THE BALLOON WAS REMOVED. IT WAS FOUND THERE WAS A LEAK NEAR THE WIRE LUMEN. A NEW ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. 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 19576731 ↗
• MalfunctionDec 21, 2023Break; Material Rupture; Material Separation; Break; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUBCLAVIAN VEIN THAT WAS MODERATELY CALCIFIED, MODERATELY STENOSED. THE 12X40MM ARMADA 35 RUPTURED DURING THE SECOND INFLATION AT 10 ATMOSPHERES (ATMS), BOTH INFLATION CYCLES WERE AT 10 ATMS. DURING REMOVAL THE BALLOON SEPARATED IN THE 6FR SHEATH. THE SEPARATED PORTION WAS REMOVED WITHOUT ISSUE, AS IT REMAINED IN THE SHEATH. ANOTHER ARMADA 35 SAME SIZE WAS USED TO CONTINUE 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 18380102 ↗
• MalfunctionDec 7, 2023Material Rupture; Material Separation; Material Rupture; Material Separation

  SUBSEQUENT TO THE INITIAL FILED REPORT, A TIP/ BALLOON SEPARATION WAS NOTED ON DEVICE ANALYSIS. FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT THE TIP SEPARATED AFTER THE SHEATH WAS PULLED OUT AND NOTHING REMAINED IN THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288575 ↗
• MalfunctionNov 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS RADIAL ARTERY THAT IS 70% STENOSED. THE 12.0X40MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT 10 ATMOSPHERES. ANOTHER ARMADA 35 BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074995 ↗
• InjuryJan 9, 2023Entrapment of Device; Difficult to Remove; Material Rupture; Material Separation; Entrapment of Device; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE AORTA VIA RIGHT FEMORAL ACCESS WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 40% STENOSIS. THE ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 10 ATMOSPHERES WHEN THE RUPTURE OCCURRED. THE CATHETER GOT CAUGHT ON CALCIUM DURING REMOVAL AND COULD NOT BE REMOVED, SO A CUTDOWN SURGERY WAS PERFORMED. THE BALLOON WAS SUCCESSFULLY REMOVED OVER THE WIRE AFTER PULLING THE BALLOON BACK INTO THE SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER. UPON INSPECTION OF THE DEVICE, CALCIUM AND BIOLOGICAL MATERIAL WERE OBSERVED LODGED IN THE BALLOON. THE PATIENT WAS HOSPITALIZED ADDITIONAL TIME BUT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16125291 ↗
• MalfunctionNov 18, 2021Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Off-Label Use; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED MID CEPHALIC VEIN. THE 12X40MM ARMADA 35 BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, IT WAS ATTEMPTED TO INFLATE AGAIN TO RATE BURST PRESSURE (RBP), BUT THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE BEFORE REACHING THE RBP. THE BALLOON RUPTURED RADIALLY AND WAS PARTLY STUCK TO THE SHEATH; THEREFORE, THE DEVICES WERE REMOVED TOGETHER. NO OTHER DEVICE WAS USED. THE INITIAL INFLATION TO NOMINAL PRESSURE OPENED UP THE STENOSIS AND HELPED WITH THE BLOOD FLOW. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENTLY, TO THE INITIAL BEING FILED THE ACCOUNT CONFIRMED THE DEVICE SEPARATED; HOWEVER, THE SEPARATED TIP WAS ATTACHED TO THE WIRE WHEN THE BALLOON WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839951 ↗
• MalfunctionAug 31, 2021Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 99% STENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS VESSEL IN THE FEMORAL ARTERY. THE 12.0X40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER FAILED TO CROSS THE TARGETED LESION DUE TO THE ANATOMY ON THE FIRST ATTEMPT AND THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED AND THE ARMADA 35 WAS ABLE TO ADVANCE ON THIS ATTEMPT, HOWEVER, DURING INFLATION IT FAILED TO HOLD THE PRESSURE. IT WAS NOTED UNDER FLUOROSCOPIC GUIDANCE THAT THERE WAS A LEAK OF CONTRAST IN THE BALLOON. ANOTHER ARMADA 35 WAS ABLE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12395253 ↗
• MalfunctionNov 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CEPHALIC ARCH VEIN. THE PATIENT PRESENT WITH STENOSIS, WHICH WAS REVEALED THROUGH A VENOUS DUPLEX SCAN. A 12.0X40MM ARMADA 35 PTA WAS ADVANCED AND INFLATED TO 10 ATMOSPHERE (ATM); HOWEVER, THE ANGIOGRAM STILL SHOWED RESIDUAL STENOSIS. A NON-ABBOTT SELF EXPANDING STENT WAS DEPLOYED INTO THE CEPHALIC ARCH VEIN. THE SAME ARMADA 35 WAS USED TO FURTHER BALLOON THE VESSEL AND THE BALLOON RUPTURED AT 9 ATM OF PRESSURE. THE DEVICE WAS SIMPLY REMOVED AND ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10856312 ↗
• MalfunctionAug 28, 2020Off-Label Use; Difficult to Remove; Material Rupture; Off-Label Use; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE AORTA ARTERY. DURING PRE-DILATATION A 12X40MM ARMADA 35 BALLOON RUPTURED AT 8 BAR DURING THE FIRST INFLATION. THE BALLOON CATHETER WAS REMOVED; HOWEVER, THE BALLOON BECAME STUCK IN THE INTRODUCER SHEATH. THE INTRODUCER SHEATH HAD TO BE REMOVED AS A UNIT WITH THE BALLOON CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REINTRODUCTION OF THE INTRODUCER SHEATH AND THE DEPLOYMENT OF A 16X40MM NON-ABBOTT STENT. 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 10468485 ↗
• InjuryJun 18, 2020Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN A PREVIOUSLY CREATED RIGHT RADIOCEPHALIC ARTERIOVENOUS (AV) FISTULA. THE PATIENT HAS A HISTORY OF STENOSIS OF THE SUBCLAVIAN/INNOMINATE VEIN, CAUSING ARM SWELLING, WITH IMPLANTATION OF AN UNSPECIFIED STENT TO TREAT THE STENOSIS. THE PATIENT PRESENTED WITH SWELLING IN HER RIGHT ARM AND THE PROCEDURE WAS PERFORMED TO TREAT STENOSIS OF THE AV FISTULA. THE 12.0 X 40 MM ARMADA 35 DILATATION CATHETER WAS ADVANCED TO THE TARGET SITE. THE BALLOON WAS INFLATED TO 5 ATMOSPHERES (ATM) AND THE BALLOON RUPTURED. AN ATTEMPT WAS MADE TO REMOVE THE DILATATION CATHETER; HOWEVER, RESISTANCE WAS NOTED AND IT WAS OBVIOUS THAT SOMETHING WAS PREVENTING THE REMOVAL OF THE DEVICE. THE DILATATION CATHETER WAS ABLE TO COME OUT OF THE SHEATH, BUT IT COULD NOT BE REMOVED FROM THE GUIDE WIRE. IT APPEARED THAT THE TIP OF THE CATHETER AND BALLOON MAY HAVE SEPARATED AND REMAINED IN THE ANATOMY. ANGIOGRAPHY NOTED THAT THE BALLOON MARKER WAS CAUGHT ON THE PREVIOUSLY IMPLANTED STENT. THE DILATATION CATHETER WAS CUT AND REMOVED FROM THE GUIDE WIRE. A 6 FRENCH NON-ABBOTT SHEATH WAS THEN ADVANCED OVER THE GUIDE WIRE AND THE GUIDE WIRE WAS REMOVED. IT

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10172131 ↗
• InjuryApr 24, 2020Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE ANASTOMOTIC PART OF RIGHT PULMONARY ARTERY. THE 12X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER A 0.035¿ NON-ABBOTT GUIDE WIRE FOR DILATATION. THE BDC MET RESISTANCE WITH ANATOMY AND FAILED TO CROSS. THE BDC WAS REMOVED AND THE GUIDE WIRE WAS REPLACED WITH A NON-ABBOTT STIFF GUIDE WIRE. THE BALLOON WAS SLIGHTLY RE-SHAPED TO A BANANA SHAPE DUE TO THE STENOSIS AND TORTUOSITY OF THE TARGET LESION BEFORE BEING RE-ADVANCED. THE BDC REACHED THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED DURING SECOND INFLATION AT AN UNSPECIFIED PRESSURE BUT BELOW THE RATED BURST PRESSURE. DURING REMOVAL OF THE BDC, RESISTANCE WITH THE INTRODUCER SHEATH WAS FELT AND THE BALLOON PART SEPARATED FROM THE SHAFT. A CUT-DOWN PROCEDURE WAS PERFORMED TO SUCCESSFULLY REMOVE THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND NO SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9998171 ↗
• InjuryMar 10, 2020Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN AV FISTULA. THE 12X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO ISSUES. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT THE RATED BURST PRESSURE (RBP). DURING RETRACTION, RESISTANCE WAS MET WITH THE ANATOMY AND THE BALLOON SEPARATED. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED PORTION FROM THE ANATOMY. 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 9811986 ↗
• InjuryMar 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A BRACHIOCEPHALIC FISTULA, THE TIP OF THE 12X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMNIAL ANGIOPLASTY (PTA) CATHETER WAS RETAINED [REMAINED IN ANATOMY]. THERE WAS NO REPORTED TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9800936 ↗
• InjuryFeb 17, 2020Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE DURING POST DILATATION USING AN ARMADA BALLOON CATHETER, THE BALLOON RUPTURED LONGITUDINAL DURING FIRST INFLATION AT 10 ATMOSPHERE. HOWEVER, DURING REMOVAL OF THE BALLOON CATHETER, THE BALLOON GOT CAUGHT WITH THE IMPLANTED STENT AND THE BALLOON SEPARATED FROM THE CATHETER. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED BALLOON FROM THE PATIENT ANATOMY. THERE WAS NOTHING LEFT INSIDE THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED, AND THE PATIENT REMAINED STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717642 ↗