Armada A2020-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08717648155987), received between Apr 12, 2018 and Sep 17, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT PERONEAL ARTERY. THE 2.0X120MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE BDC WAS REMOVED AND THE PROCEDURE COMPLETED USING ANOTHER ARMADA 14. 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 23071998 ↗
• MalfunctionMay 20, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. THE 2X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT AND THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT 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 22057478 ↗
• MalfunctionMay 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE ILIAC ARTERY. A 2X120MM ARMADA 14 BALLOON DILATATION CATHETER WAS PREPARED AND ADVANCED TO THE LESION WITH NO ISSUES; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATM. THEREFORE, THE BDC WAS REMOVED AND A NEW SAME SIZED ARMADA 14 BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010501 ↗
• MalfunctionApr 18, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY THAT IS 75% STENOSED. A 2.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER A COMMAND ES GUIDEWIRE. THE ARMADA BALLOON WAS INFLATED ONCE AT NOMINAL PRESSURE, AND WAS NOTED LOSING PRESSURE AND ONLY PARTIALLY INFLATED AS LEAK WAS OBSERVED AT THE HUB. A NEW 2.5X120MM 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 21867423 ↗
• MalfunctionFeb 18, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A DISTAL POSTERIOR TIBIAL ARTERY THAT WAS MILDLY CALCIFIED. AFTER THE DIAMONDBACK 360 WAS USED SUCCESSFULLY. AN ARMADA 14 BALLOON WAS INSERTED ALONG WITH THE VIPERWIRE. DURING REMOVAL OF THE GUIDE WIRE, THE TIP MET RESISTANCE WITH THE BALLOON AND BECAME STUCK IN THE SHAFT OF THE BALLOON. AN ATTEMPT WAS MADE TO REMOVE THE DEVICES INDEPENDENTLY; HOWEVER, WAS UNSUCCESSFUL. BOTH DEVICES WERE REMOVED TOGETHER. THE BALLOON SHAFT WAS OBSERVED TO BE FOLDED LIKE AN ACCORDION ONCE OUTSIDE THE ANATOMY. A 2.0X150 ARMADA AND AN NON-ABBOTT GUIDE WIRE WERE 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 21396055 ↗
• MalfunctionNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESON IN THE RIGHT COMMON FEMORAL ARTERY (RCF). A 2.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO LESION AND ATTEMPTED TO BE USED FOR VESSEL DILATION; HOWEVER, DURING THE THIRD INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8 ATMOSPHERES. THE ARMADA 14 WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724076 ↗
• MalfunctionJan 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN AN UNSPECIFIED VESSEL. THE 3.0X80 MM ARMADA 14 AND 2.0X120 MM ARMADA 14 BALLOON DILATATION CATHETERS (BDC) WERE PREPARED WITHOUT ISSUE. THE 3X80 MM ARMADA BDC WAS ADVANCED TO THE LESION AND INFLATED, HOWEVER IT RUPTURED AT 6 ATMOSPHERES DURING THE THIRD INFLATION. THE BALLOON WAS REMOVED WITHOUT ISSUE. THE 2X120 MM ARMADA BDC WAS THEN ADVANCED TO THE LESION AND INFLATED; HOWEVER, IT ALSO RUPTURED AT 6 ATMOSPHERES DURING THE SECOND INFLATION. THE BALLOON WAS REMOVED WITHOUT ISSUE. A 0.9 LASER AND MINI TREK BALLOON WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610320 ↗
• MalfunctionOct 26, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED RIGHT POSTERIOR TIBIAL ARTERY. THE 2.0X120 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND WAS ADVANCED TO THE LESION AND INFLATED TO NOMINAL PRESSURE. IT WAS NOTED THAT THE DEVICE WAS NOT HOLDING PRESSURE BUT IT WAS HOLDING CONTRAST AND THERE WAS A LEAK OF FLUID OUTSIDE THE ANATOMY AT THE HUB OF THE DEVICE. THEREFORE, THE DEVICE WAS REMOVED AND A 2.0X100 ARMADA 14 PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE SAME INDEFLATOR WAS USED WITH BOTH BALLOONS. 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 18016407 ↗
• MalfunctionAug 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT POSTERIOR TIBIAL ARTERY THAT WAS CALCIFIED. REPORTEDLY, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. ANOTHER ARMADA 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 17603920 ↗
• MalfunctionMar 23, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 80% STENOSED LESION IN THE ANTERIOR TIBIAL ARTERY AND POPLITEAL ARTERY. A 2.0X120MM/150CM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE FROM THE ANATOMY AND INFLATED ONE TIME TO NOMINAL PRESSURE OF 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A NEW 2.0X200MM ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16603368 ↗
• MalfunctionMar 9, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT POSTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU), HOWEVER, THERE WAS RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 9 ATMOSPHERES (ATMS). ANOTHER SAME SIZE ARMADA 14 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 16512893 ↗
• MalfunctionFeb 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 2.0X120MM/150CM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME TO UNKNOWN ATMOSPHERES (ATM), WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE AND A SECOND BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16392613 ↗
• MalfunctionJul 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED PERONEAL ARTERY, VIA ANTEGRADE APPROACH. THE ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED TO THE LEION WITHOUT DIFFICULTY. THE BALLOON WAS INFLATED 1 TIME TO 12 ATMOSPHERES (ATM) AND A BALLOON RUPTURE OCCURRED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND NO ADVERSE PATIENT EFFECT OCCURRED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007966 ↗
• MalfunctionMar 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT POSTERIOR TIBIAL. THE 2.0X120MM ARMADA BALLOON DILATATION CATHETER RUPTURED DURING USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 13683380 ↗
• MalfunctionJan 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE PERONEAL ARTERY THAT WAS HEAVILY CALCIFIED, MILDLY TORTUOUS AND 60% STENOSED. THE ARMADA 14 BALLOON CATHETER WAS ADVANCED TO THE REGION OF THE DISTAL MIDDLE THIRD OF THE PERONEAL ARTERY, AND BEGAN TO INFLATE, BUT PRESSURE DID NOT RAISE UNDER FLUOROSCOPY. IT WAS OBSERVED THAT CONTRAST WAS LEAKING AT THE HUB. THE DEVICE WAS REMOVED AND ANOTHER ARMADA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED 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 13197067 ↗
• MalfunctionDec 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE RIGHT ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 2.0 X 120 ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. HOWEVER, ON THE FIFTH INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THEREFORE, THE BDC WAS REMOVED AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BALLOON 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 12980365 ↗
• MalfunctionNov 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, RIGHT PERONEAL ARTERY. THE 2.0MM X 120MM X 150CM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. HOWEVER, DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 6 ATMOSPHERES. A NEW, SAME SIZE ARMADA 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 12756383 ↗
• MalfunctionOct 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERIPHERAL PERCUTANEOUS INTERVENTION ON THE PERONEAL ARTERY, CALCIFIED LESION. AN ARMADA BALLOON CATHETER ADVANCED TO THE LESION SITE WITHOUT AN ISSUE REPORTED. DILATATION WAS PERFORMED AT 8 ATMOSPHERES WHEN THE BALLOON BURST. THE DEVICE WAS REMOVED WITHOUT ISSUE. ANOTHER ARMADA DILATATION CATHETER ADVANCED TO THE LESION WITHOUT AN ISSUE NOTED. DURING BALLOON DILATATION AT 10 ATMOSPHERES, THIS BALLOON ALSO BURST. THE DEVICE WAS REMOVED WITHOUT FURTHER ISSUES. ANOTHER ARMADA CATHETER WAS SUCCESSFULLY USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615662 ↗
• MalfunctionFeb 26, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. A 2X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS ADVANCED WITHOUT RESISTANCE. THE BALLOON COMPLETELY FAILED TO INFLATE WHILE LOSING PRESSURE AS A BALLOON RUPTURE WAS NOTED. A 2.5X60MM ARMADA 14 PTA WAS ADVANCED, AND THE BALLOON PARTIALLY INFLATED ONLY UP TO 4 ATMOSPHERES BUT WAS ALSO LOSING PRESSURE AS A PINHOLE BALLOON RUPTURE WAS NOTED. A 2X60MM 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 11388439 ↗
• MalfunctionSep 8, 2020Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A 90% STENOSED, HEAVILY CALCIFIED AND MODERATELY TORTUOSITY LESION IN THE ANTERIOR TIBIAL ARTERY. A COMMAND ES GUIDE WIRE SUCCESSFULLY CROSSED THE LESION. A 2.0X120MM ARMADA 14 BALLOON CATHETER WAS PREPARED WITH NORMAL SALINE AND WAS ADVANCED TO THE LESION. THE COMMAND ES GUIDE WIRE WAS WITHDRAWN AND THEN ATTEMPTED TO BE ADVANCED THROUGH THE BALLOON CATHETER TO DILATE THE ANTERIOR TIBIAL ARTERY. THE GUIDE WIRE MET RESISTANCE WHEN ADVANCING THROUGH THE BALLOON CATHETER AND FAILED TO PASS AFTER REPEATED ATTEMPTS. AFTER WITHDRAWING THE BALLOON CATHETER, IT WAS NOTED THAT THE INNER MEMBER OF THE SHAFT WAS TORN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 2.0X120MM ARMADA 14 BALLOON CATHETER. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10503023 ↗
• MalfunctionMar 24, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS FAULTY. THE BDC WAS UNABLE TO USE/INFLATE AS LIQUID WAS LEAKING OUT AT DISTAL END NEAR BLACK CONNECTION. THE METHOD USED TO COMPLETE THE PROCEDURE WAS NOT PROVIDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9874072 ↗
• MalfunctionSep 21, 2018Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION OF THE DISTAL POSTERIOR TIBIAL ARTERY THAT WAS MODERATELY CALCIFIED. AN UNSPECIFIED 014 COMMAND GUIDE WIRE WAS ADVANCED TOWARDS THE LESION, AND A 2.0 X 120 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED. HOWEVER, THE BDC FAILED TO CROSS THE LESION AFTER SEVERAL ATTEMPTS WERE MADE AS IT BECAME CAUGHT WITH THE GUIDE WIRE. THEREFORE, THE ARMADA BDC WAS REMOVED INDEPENDENTLY FROM THE ANATOMY. A 2.0 X 120 MM NON-ABBOTT BDC WAS THEN USED WITH THE SAME GUIDE WIRE 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 7898785 ↗
• MalfunctionAug 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE ANTERIOR TIBIAL (AT) ARTERY, DURING THE INITIAL INFLATION OF THE ARMADA BALLOON DILATATION CATHETER (BDC), THE BALLOON RUPTURED BELOW NOMINAL PRESSURE AT THE LESION. THE DEVICE WAS REMOVED AND A DIFFERENT BDC WAS USED IN THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7770474 ↗
• MalfunctionApr 12, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED PROXIMAL POSTERIOR TIBIAL ARTERY USING A 2.0 X 120 MM ARMADA 14 BALLOON CATHETER. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION. REPORTEDLY, THE BALLOON RUPTURED DURING THE 2ND OR 3RD INFLATION AT 10 ATMOSPHERES. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7427189 ↗