Armada A2030-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08717648156106), received between Oct 11, 2016 and Jun 9, 2026 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (20 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE 3.0X120MM ARMADA 14 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER DURING INFLATION THE SHAFT LEAKED. 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 25443008 ↗
• MalfunctionNov 25, 2025Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE PERIPHERAL ARTERIES. THE 3.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE PATIENT HOWEVER IT WAS NOTED THE RADIOPAQUE MARKERS INSIDE THE BALLOON WERE MOVING FREELY WITHIN THE BALLOON. THE BDC WAS REMOVED AND REPLACED WITH ANOTHER DEVICE 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 23643615 ↗
• MalfunctionOct 8, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE TIBIOFIBULAR TRUNK WITH OCCLUSION. THE 3X120 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER DID NOT ADEQUATELY INFLATE AND LOST PRESSURE. A DIFFERENT BALLOON 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 20401670 ↗
• MalfunctionOct 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE PERONEAL ARTERY. THE 3.0X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION. THE BALLOON WAS INFLATED; HOWEVER IT WOULD NOT REACH NOMINAL PRESSURE. THE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT RESISTANCE AND A HOLE WAS NOTED ON THE BALLOON. ANOTHER ARMADA 14 DILATATION 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 20384500 ↗
• MalfunctionOct 7, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE TIBIOPERONEAL TRUNK (TPT) AND PERONEAL ARTERY. A 3X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONCE TO 8ATM; HOWEVER, AFTER DILATATION THE BALLOON FAILED TO DEFLATE. AFTER SEVERAL ATTEMPTS TO DEFLATE THE BALLOON, THE BDC WAS REMOVED INFLATED AND ANOTHER 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 20384117 ↗
• MalfunctionJun 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY WITH THE 3.0X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE BALLOON WAS ADVANCED WITH NO RESISTANCE AND INFLATED ONCE TO 4 ATMOSPHERES AND RUPTURED. A SAME SIZE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625876 ↗
• MalfunctionFeb 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED DE NOVO LESION IN THE TIBIAL ARTERY WITH HEAVY CALCIFICATION. A 3X200MM AND A 3X120MM ARMADA BALLOON DILATATION CATHETER (BDC) WERE USED IN A PROCEDURE. HOWEVER, THE BALLOONS RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THERE WAS NO ADVERSE PATIENT EFFECT AND CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743591 ↗
• MalfunctionOct 4, 2023Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LEFT INTERNAL CAROTID ARTERY THAT IS 90% STENOSED. A VIATRAC CAROTID BALLOON WAS NOT AVAILABLE; THEREFORE, THE 3.0X120MM ARMADA 14 BALLOON CATHETER WAS INFLATED TO 8 ATMOSPHERES; HOWEVER, WOULD NOT INFLATE. THE DEVICE WAS LOSING PRESSURE WHEN ATTEMPTING TO INFLATE. THE PRESSURE WAS RELEASED TO PULL BACK THE PRESSURE PUMP. BLOOD WAS FOUND TO FLOW BACK THE PRESSURE PUMP. ANOTHER ARMADA 14 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 17873760 ↗
• MalfunctionSep 7, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. THE 3.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 8 ATMOSPHERES, HOWEVER, A LEAK WAS NOTED ON THE DELIVERY SYSTEM AT THE HUB. A NEW 3.0X200MM ARMADA 14 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703263 ↗
• MalfunctionAug 28, 2023Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY WITH MILD CALCIFICATION AND A CONTRAST MIX OF 50% SALINE AND 50% CONTRAST. THE 3.0X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS INFLATED ONCE AND A RUPTURE OCCURRED AT 4 ATMOSPHERES. IT IS POSSIBLE THAT A PIECE OF THE BALLOON MAY HAVE REMAINED IN THE INDEFLATOR; HOWEVER, IT WAS CONFIRMED THAT NOTHING REMAINED IN THE PATIENT. ANOTHER 4.0X80MM ARMADA 14 PTA WAS INFLATED ONCE AT 18 ATMOSPHERES; HOWEVER, DESPITE THE BALLOON WAS IN NEGATIVE HELD FOR TWENTY SECONDS, COULD NOT BE DEFLATED. A NON-ABBOTT INDEFLATOR WAS USED, BUT THE ISSUE PERSISTED AND WAS REMOVED PARTIALLY DEFLATED BUT AS A SINGLE UNIT. THERE WAS RESISTANCE DURING REMOVAL WITH EITHER THE PIECE OF BALLOON OR THE CATHETER. ANOTHER ARMADA 14 WAS 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 17633761 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. THE ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER SHAFT WAS NOTED BROKEN. ANOTHER ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. 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 17379247 ↗
• MalfunctionJun 1, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) HAD ISSUES WHEN TRYING TO SCREW THE INFLATION DEVICE ON THE CATHETER. UPON FIXING THE INFLATION DEVICE MANUALLY AGAINST THE BALLOON LUMEN, THERE WAS NO PRESSURE BUILD UP. ANOTHER 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 17040036 ↗
• MalfunctionMar 29, 2023Difficult to Insert; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Insert; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUBSEQUENT TO TO THE INITIAL FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE GUIDE WIRE WAS REMOVED AND THEN A SECOND GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED THROUGH THE ARMADA PORT, WHILE AT THE TARGET LESION, IN ORDER TO INJECT CONTRAST FOR IMAGING PURPOSES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640080 ↗
• MalfunctionJan 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  USER FACILITY MEDWATCH REPORT RECEIVED STATING: ARMADA 14 PTA CATHETER USED DURING THE SURGICAL PROCEDURE (LEFT LOWER EXTREMITY ANGIOGRAM/ANGIOPLASTY) AND THE HI TORQUE COMMAND ES GUIDE WIRE WAS PUSHED THROUGH THE CATHETER IN THE APPROPRIATE MANNER, AND ON XRAY NOTICED THE WIRE PUSHED THROUGH THE BALLOON ON THE END OF THE CATHETER. CATHETER AND THE GUIDEWIRE IMMEDIATELY WITHDRAWN AND FOUND THE GUIDE WIRE PROTRUDING THROUGH THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16179104 ↗
• MalfunctionDec 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY. A 3.0X120X150CM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION FOR PRE-DILATATION. THE BALLOON WAS INFLATED ONE TIME TO 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 3.0X100X150CM ARMADA 14 BDC WAS USED AS A REPLACEMENT DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965446 ↗
• MalfunctionOct 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 3.0X120MM ARMADA 14 BALLOON DILATATION CATHETER RUPTURED DURING THE PROCEDURE. ANOTHER BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE 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 15640553 ↗
• MalfunctionSep 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS POSITIONED AND AS THE PHYSICIAN WANTED TO CHANGE THE GUIDEWIRE, THE HI-TORQUE (HT) COMMAND 14 GUIDEWIRE WENT INTO THE WRONG BALLOON LUMEN [TEAR TO ARMADA 14 BALLOON]. THE ARMADA 14 BALLOON AND HT COMMAND 14 GUIDEWIRE HAD TO BE REMOVED. A NEW ARMADA AND GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473341 ↗
• MalfunctionMay 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED, NON-TORTUOUS ANTERIOR TIBIAL ARTERY. A 3X120MM ARMADA 14 BALLOON WAS ADVANCED TO THE LESION AND WHEN INFLATED AT ABOUT 6-8 ATMOSPHERES, LEAKAGE WAS NOTED AT THE HUB OF THE DEVICE (BETWEEN CATHETER AND CONNECTION). NO OTHER DAMAGE TO THE DEVICE WAS NOTED. NO AIR ENTERED THE PATIENT. THE DEVICE DID NOT LEAK DURING PREP PHASE. ANOTHER SAME SIZE ARMADA 14 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292811 ↗
• MalfunctionFeb 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT CHRONIC LIMB ISCHEMIA. THE 3.0X120MM ARMADA 14 BALLOON DILATATION CATHETER WAS NOTED TO RUPTURE DURING THE PROCEDURE AT AN UNKNOWN PRESSURE. ANOTHER ARMADA 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 13586085 ↗
• MalfunctionSep 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY. TWO BALLOONS (3X120MM ARMADA 14 AND 3X150MM ARMADA 18) WERE USED AND BOTH RUPTURED WHEN THEY WERE INFLATED ONCE AT 14 ATMOSPHERES. ANOTHER SMALLER SIZED 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 12476674 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT PERONEAL ARTERY LESION. PRE-DILATATION WAS SUCCESSFULLY PERFORMED USING ARMADA CATHETERS AND A 4.0X18MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED. ANGIOPLASTY WAS THEN PERFORMED USING ARMADA DILATATION CATHETERS IN THE DORSALIS PEDAL ARTERY WITH SUBTOTAL OCCLUSION. FOLLOWING USE OF ARMADA (A2030-120, 0112541), A THROMBUS/EMBOLISM WAS OBSERVED IN THE PROXIMAL PEDAL ARTERY, SUCCESSFULLY TREATED WITH A THROMBECTOMY. THE EVENT RESOLVED WITHOUT SEQUELA. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Embolism/Embolus

  MAUDE report 12051970 ↗
• MalfunctionMar 30, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS TIBIAL ARTERY THAT WAS 75% STENOSED. THE 3.0X12MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED OVER A COMMAND ES GUIDEWIRE. DURING INFLATION, THE BALLOON DID NOT OPEN TO ITS COMPLETE PROFILE AND A LEAK WAS OBSERVED FROM THE HUB. THE DEVICE WAS REPLACED WITH A 3.0X200MM ARMADA 14 BALLOON 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592418 ↗
• MalfunctionOct 13, 2020Off-Label Use; Failure to Advance; Device Damaged by Another Device; Off-Label Use; Failure to Advance; Device Damaged by Another Device

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH SHORT CHRONIC TOTAL OCCLUSION. A 6F SHEATH WAS USED. THE VESSEL WAS 6 MM AND LASER ATHERECTOMY WAS PERFORMED. A 6.0X120 MM SUPERA SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND DEPLOYED. FLUOROSCOPY WAS USED TO CONFIRM THE STENT HAD FULLY EMERGED/DEPLOYED WHEN REMOVING THE DELIVERY SYSTEM. HOWEVER, WHEN A BALLOON WAS BEING ADVANCED FOR POST DILATATION, THE STENT SEEMED BLOCKED AND IT WAS OBSERVED THAT THE SUPERA TIP HAD SEPARATED AND WAS STUCK AT THE PROXIMAL ENTRY OF THE SUPERA STENT. THE SHEATH THAT WAS ALREADY IN THE ANATOMY WAS ADVANCED TO CAPTURE THE TIP BUT ALSO REMOVED THE IMPLANTED STENT. NO ADDITIONAL STENT WAS IMPLANTED. MANUAL PRESSURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS NOTED THAT THE 6F SHEATH WAS RETURNED WITH A 3.0 ARMADA 14 BALLOON CATHETER INSERTED INSIDE. IT APPEARS THAT THE BALLOON HAD BEEN INFLATED AND WAS LIKELY USED TO HELP REMOVE THE SEPARATED TIP AND SUBSEQUENTLY THE IMPLANTED STENT. IT WAS CONFIRMED THAT TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670949 ↗
• MalfunctionOct 9, 2020Inflation Problem; Leak/Splash; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED ARTERY. A 3.0 X 120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED; HOWEVER, THE BALLOON FAILED TO INFLATE DURING FIRST INFLATION. ANOTHER UNSPECIFIED BALLOON CATHETER WAS 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. RETURNED DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS TORN AND BALLOON DID NOT INFLATE AND FLUID WAS OBSERVED COMING OUT OF THE NOTED TEAR IN THE SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10659472 ↗
• MalfunctionSep 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED CHRONIC TOTALLY OCCLUDED LESION IN THE ANTERIOR TIBIAL ARTERY. REPORTEDLY, A 3.0MM/120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED ONCE AND RUPTURED AT 6 ATMOSPHERES (ATM). A 3.0MM/200MM ARMADA 14 PTA BALLOON CATHETER WAS INFLATED ONCE AND RUPTURED AT 4 ATM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SMALLER UNSPECIFIED BALLOON DILATATION CATHETER FOR PRE-DILATATION AND LASER ATHERECTOMY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511904 ↗