Armada A2020-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08717648155994), received between Aug 2, 2016 and Aug 6, 2026 — classified as 4 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (31 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Inflation Problem; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165144 ↗
• MalfunctionJun 3, 2026Inflation Problem; Difficult to Remove; Material Rupture; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FEMORAL ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.0X200 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATED; HOWEVER, IT WAS NOTED THAT THE BALLOON WAS SMALLER THAN EXPECTED. THE DEVICE WAS INFLATED THREE TIMES TO NOMINAL AND RATED BURST PRESSURE. THE BALLOON WAS REMOVED FOR INSPECTION AND IT WAS NOTED TO BE COLLAPSED "[RUPTURED]". A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382419 ↗
• MalfunctionDec 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. ONCE AT THE LESION, THE BALLOON OF THE 2.0X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. A 2.0X120MM ARMADA 14 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 23928056 ↗
• MalfunctionFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE POPLITEAL ARTERY. AFTER A 2X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO ISSUES THE BDC WAS ATTEMPTED TO BE USED TO DILATE THE LESION; HOWEVER, DURING ITS FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 14 ATMOSPHERES (ATM). THE BDC WAS REMOVED AND THE VESSEL WAS ATTEMPTED TO BE DILATED WITH A 2X200MM ARMADA 14 BDC, AFTER BEING PRE-PREPARED WITH NO ISSUES, BUT DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 12ATM. THE BDC WAS REMOVED AND REPLACED WITH A SAME SIZED ARMADA 14 BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327029 ↗
• MalfunctionSep 17, 2024Difficult to Remove; Failure to Advance; Difficult to Advance; Difficult to Remove; Failure to Advance; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED A NON-ABBOTT BALLOON WAS USED TO ADVANCE OVER THE WIRE FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE. THE ARMADA HAD ADVANCEMENT ISSUES AND 'STINKING' WITH BOTH WIRES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238792 ↗
• MalfunctionSep 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE WITH THE 2X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC), THE BALLOON STOPPED WORKING WHEN INFLATION REACHED 12 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS CONTINUED. DURING THE PROCEDURE UNDER FLUOROSCOPY CONTRAST WAS DIFFUSING OUT OF THE BALLOON. 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 20231452 ↗
• MalfunctionAug 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE VESSEL WAS MILDLY TORTUOSITY, MODERATELY CALCIFIED AND 70% STENOSED. THE 2.0X200MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION WITHOUT ANY RESISTANCE. HOWEVER, DURING THE SECOND INFLATION TO 8 ATMOSPHERES THE BALLOON LOST PRESSURE. THE BALLOON DID NOT INFLATE ABOVE NOMINAL PRESSURE. AN ISSUE WITH THE INFLATION DEVICE WAS SUSPECTED BUT AFTER THE INFLATION DEVICE WAS CHANGED, THE SAME RESULT WAS OBTAINED. THE ARMADA CATHETER WAS REMOVED AND WAS TESTED ON THE TABLE, THE CATHETER DID NOT HAVE A LEAK, IT SIMPLY DID NOT INFLATE. A DIFFERENT BALLOON, BRAND WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19962140 ↗
• MalfunctionJun 4, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN AN UNSPECIFIED ARTERY. THE 2.0X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS LEAKING AT THE VALVE CONNECTION SITE. ANOTHER ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463930 ↗
• MalfunctionApr 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WHICH WAS PREPPED PER INSTRUCTION OF USE, RUPTURED BEFORE REACHING NOMINAL PRESSURE. 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 19165647 ↗
• MalfunctionApr 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE ANTERIOR TIBIAL ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 99% STENOSED. THE ARMADA 14 BALLOON RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE DUE TO HEAVILY CALCIFICATION. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 19126592 ↗
• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SEVERELY CALCIFIED TIBIAL ARTERY. THE SPARTACORE GUIDE WIRE WAS ADVANCED HOWEVER, IT BECAME CAUGHT ON CALCIUM AND THE GUIDE WIRE WAS STRETCHED. THERE WAS NO CORE OR COILS SEPARATION AND THE GUIDE WIRE WAS REMOVED WITHOUT RESISTANCE. AN ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ATTEMPTED TO BE INFLATED ONCE TO 10 ATMOSPHERES BUT RUPTURED AT 1 ATMOSPHERE. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321399 ↗
• MalfunctionApr 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN THE ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2.00X200MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THEN, WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE. HOWEVER, A BALLOON RUPTURE OCCURRED 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. ANOTHER SAME SIZE ARMADA WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734124 ↗
• InjuryFeb 24, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION (MI). THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE LESION IN THE RIGHT SUPERIOR FEMORAL ARTERY (SFA). A 5.0X100MM ON 135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) BALLOON WAS ADVANCED TO THE LESION BUT RUPTURED BEFORE REACHING NOMINAL PRESSURE DURING THE FIRST INFLATION. A 5.0X150MM 135CM ARMADA 35 BDC WAS USED TO CONTINUE THE PROCEDURE. A 6.0X200MM ON 135CM ARMADA 35 BDC BALLOON WAS ADVANCED TO THE LESION BUT RUPTURED BEFORE REACHING NOMINAL PRESSURE DURING THE FIRST INFLATION. A 6.0X100MM 150CM NON-ABBOTT DEVICE WAS USED TO CONTINUE THE PROCEDURE. A 2.0X200MM ON 150CM ARMADA 14 BDC WAS ADVANCED, BUT THE BALLOON TIP AND DISTAL SHAFT BECAME STUCK IN THE VESSEL WHILE PULLING BACK THE BALLOON AND SEPARATED. THE PLAN WAS TO SCHEDULE A RETRIEVAL OF THE SEPARATED DEVICE THAT REMAINED IN THE PATIENT, THE NEXT DAY, BUT DUE TO CATH LAB AVAILABILITY, IT WAS POSTPONED ONE MORE DAY. THE PATIENT PASSED AWAY ON THE SECOND DAY AFTER THE ANGIOPLASTY PROCEDURE DUE TO THE EFFECTS OF THE MI. IN THE PHYSICIAN'S OPINION, THE DEATH AND MI, WERE NOT RELATED TO ANY OF

  Patient problems: Foreign Body In Patient

  MAUDE report 16440451 ↗
• InjuryDec 24, 2022Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 2.0X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) HAD SLIGHT RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND WAS INFLATED ONCE TO A NOMINAL 8 ATMOSPHERES (ATMS) FOR A THREE MINUTE INFLATION. NEGATIVE WAS HELD FOR 5 SECONDS TO DEFLATE THE BALLOON. THE BALLOON WAS FULLY DEFLATED UPON REMOVAL. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL AND SLIGHT FORCE WAS APPLIED. THE BALLOON GOT STUCK IN THE ANATOMY AND WAS LEFT IN THE PATIENT'S LEG. THE SEPARATED BALLOON WAS STUCK/EMBEDDED IN THE TIBIAL ARTERY. NO ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION. AT THE MOMENT THE PATIENT'S FOOT SEEMS TO BE RECEIVING BLOOD FROM OTHER VESSELS AND A BYPASS SURGERY HAS BEEN PLANNED IN THE FUTURE. THERE WAS A DELAY IN MAKING A DECISION IN THE NEXT STEP IN THE PROCEDURE. THE PATIENT WAS DISCHARGED AND WILL RETURN FOR THE BYPASS SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16045794 ↗
• MalfunctionDec 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. A 2.0X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BDC APPEARED NOT TO INFLATE. THE BDC WAS REMOVED AND TESTED OUTSIDE THE PATIENT ANATOMY WHEN A PERFORATION WAS OBSERVED. 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 16018510 ↗
• MalfunctionDec 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT POSTERIOR TIBIAL ARTERY. A 2X200MM ARMADA 14 BALLOON WAS ADVANCED WITHOUT ANY RESISTANCE TO THE TARGET LESION AND INFLATED ONCE WHEN IT RUPTURED AT 12 ATMOSPHERES (ATM). A SECOND 3X200MM ARMADA 14 BALLOON WAS ADVANCED WITHOUT RESISTANCE BUT WHEN INFLATED ONCE IT RUPTURED AT 14 ATM. A NON-ABBOTT BALLOON (CSI) 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 15900765 ↗
• MalfunctionOct 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION AND NO TORTUOSITY AND ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 5.0X120MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) ADVANCED WITHOUT ANY RESISTANCE NOTED AND RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION. ANOTHER 5.0X200MM ARMADA 18 (BDC) WAS THEN ADVANCE WITHOUT RESISTANCE NOTED AS WELL, HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES (ATMS). THE BALLOON PRESSURE WAS HELD FOR ABOUT 2 MINUTES AND AT ABOUT 1.5 MINUTES IT RUPTURED. THE 2.0X200MM ARMADA 14 BDC WAD ADVANCED TO THE ANTERIOR TIBIAL ARTERY WITHOUT RESISTANCE BUT ALSO RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION. AGAIN, THE PRESSURE WAS HELD FOR 2 MINUTES BUT THIS TIME RUPTURED AFTER ABOUT A MINUTE. ALL DEVICES WERE PREPARED PER INSTRUCTIONS FOR USE (IFU). NON-ABBOTT BALLOONS WERE USED TO COMPLETE THE PROCEDURE FOR THE SFA AND THE ANTERIOR TIBIAL ARTERY. 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 15676022 ↗
• MalfunctionJul 26, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR TIBIAL ARTERY. THE 2.0X200MM ARMADA 14 LOST PRESSURE AND LEAKED BELOW THE HUB WHEN IT REACHED 6 ATMOSPHERES DURING THE PROCEDURE. THERE WAS NO ISSUE WITH REMOVING THE DEVICE. ANOTHER ARMADA 14 WAS USED TO SUCCESSFULLY 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 15108022 ↗
• MalfunctionJul 26, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE ARMADA BALLOON WAS INSERTED AND WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY; HOWEVER, THE BALLOON WAS UNABLE TO INFLATE OR MAY HAVE BEEN ABLE TO INFLATE, AND HOLD PRESSURE, BUT THE INFLATION WAS INCOMPLETE. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS ON 7/7/2022 INDICATED A MATERIAL RUPTURE (LONGITUDINAL, BALLOON, PROXIMAL SEAL AND OUTER MEMBER) OF THE PROXIMAL PORTION OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107616 ↗
• MalfunctionJun 17, 2022Inflation Problem; Leak/Splash; Difficult to Remove; Contamination /Decontamination Problem; Inflation Problem; Leak/Splash; Difficult to Remove; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT PERONEAL ARTERY WITH RIGHT GROIN ACCESS. A SPARTACORE GUIDE WIRE WAS ADVANCED AND THE 2.0X200MM ARMADA 14 BALLOON CATHETER WAS ADVANCED. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH AND THE BALLOON WAS PREPARED/FLUSHED PRIOR TO USE. THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT THERE WAS A LOT OF RESISTANCE. IT TOOK A LOT OF PRESSURE TO INFLATE THE BALLOON AND IT WAS ONLY PARTIALLY INFLATED AND NOT UNIFORMLY SHAPED. THE DEVICE WAS LOSING PRESSURE BUT THERE WAS NO LEAK OF CONTRAST NOTED IN THE VESSEL AS THE BALLOON WAS INFLATING, NOR WAS THERE ANY BLOOD BACKFILLING THE INFLATION DEVICE SO IT WAS DIFFICULT TO TELL IF THERE WAS A RUPTURE. WHEN ATTEMPTING TO REMOVE THE ARMADA BALLOON, IT BECAME STUCK WITH THE SPARTACORE GUIDE WIRE IN THE SUPERFICIAL FEMORAL ARTERY AND THEY WERE PULLED OUT TOGETHER, CAUSING WIRE ACCESS TO BE LOST. THERE WAS NO ATTEMPT MADE TO MOVE THE GUIDE WIRE WHILE THE BALLOON WAS PRESSURIZED/INFLATED. THE PHYSICIAN NOTED A THREAD OF WHAT SEEMED TO BE PLASTIC MATERIAL AT THE HUB OF THE ARMADA SHEATH AND PULLED IT OUT WITHOUT INTERVENTION. IT WAS A LONG PLASTIC MATERIAL BUT ANGIOGRAPHY POST PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734853 ↗
• MalfunctionJun 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION (BELOW THE KNEE). A 2X200MM ARMADA 14 BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE AND WHEN INFLATED IT RUPTURED AT 2 ATMOSPHERES. ANOTHER 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 14651199 ↗
• MalfunctionMar 15, 2022Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Difficult to Advance; Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY AND POSTERIOR TIBIAL ARTERY BELOW THE KNEE WHICH WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS THE 2.0X200 ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS USED ONCE WITHOUT ISSUE. DURING THE SECOND USE, THE ARMADA BALLOON CATHETER WAS ATTEMPTED TO BE USED AND THE GUIDE WIRE LUMEN BECAME CURLED AND WOULD NOT ALLOW A GUIDE WIRE TO BE ADVANCED. THE LUMEN APPEARS KINKED AND BENT INSIDE THE CATHETER. IT WAS ALSO NOTED THAT THE BALLOON MARKERS WERE DIFFICULT TO SEE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT 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 13773617 ↗
• MalfunctionOct 21, 2021Product Quality Problem; Component Misassembled; Product Quality Problem; Component Misassembled

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, IT WAS NOTICED THAT THE PROXIMAL MARKER BAND ON THE CATHETER SEEMED SEPARATED AND HAD A RAISED BUBBLE. A GAP WAS FELT BETWEEN THE MARKER BAND AS IF IT WERE NOT A SOLID PIECE. THE DEVICE WAS NOT USED, THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICAL SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677915 ↗
• InjuryAug 9, 2021Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DURING AN INTERVENTION IN THE LEFT SUPERFICIAL FEMORAL ARTERY WITH MODERATE STENOSIS, AFTER INFLATING THE ARMADA 14 BALLOON AT THE LESION, THE BALLOON COMPLETELY FAILED TO DEFLATE. A DEVICE WAS USED TO PUNCTURE THROUGH THE PATIENT'S LEG AND INTO THE BALLOON TO RUPTURE IT. ONCE RUPTURED, THE DEVICE WAS EASILY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED 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 12294637 ↗
• MalfunctionJul 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE TIBIAL ARTERY. A 2.0X200MM ARMADA 14 BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BALLOON CATHETER WAS BEING USED TO PRE-DILATE THE LESION; HOWEVER, A BALLOON RUPTURE WAS NOTED DURING THE FIRST INFLATION WHEN INFLATED TO NOMINAL PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.5X120MM ARMADA 14 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 12205796 ↗