Armada B2060-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08717648155321), received between Jan 6, 2017 and Jun 17, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY LESION. A 6X200 MM ARMADA 35 LL BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WITHOUT ISSUE. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 4 ATM. AN ADDITIONAL 6X200 MM ARMADA 35 LL 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 25539881 ↗
• MalfunctionApr 21, 2026Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 6.0X200MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED AT 14 ATMOSPHERES DURING THE THIRD INFLATION. THE BDC WAS REMOVED AND ANOTHER ARMADA 35 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 24939157 ↗
• MalfunctionApr 9, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSED MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. SUBSEQUENT TO LASER ATHERECTOMY, THE 6.0X200MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WHEN RESISTANCE WAS MET DUE TO CALCIFICATION. ONCE AT THE LESION, THE ARMADA 35 BALLOON RUPTURED AT 9 ATMOSPHERES DURING THE FIRST INFLATION. A NEW 6.0X200MM ARMADA 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 24832608 ↗
• MalfunctionFeb 5, 2026Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X200MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) USED IN THE PROCEDURE AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE. HOWEVER, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN PULLED NEGATIVE SEVERAL TIMES AND THE BALLOON STARTED DEFLATING. THE BALLOON WAS REMOVED WITHOUT ISSUE PARTIALLY DEFLATED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265515 ↗
• MalfunctionSep 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN SUPERFICIAL FEMORAL ARTERY (SFA). TWO 6X200MM ARMADA BALLOON DILATATION CATHETERS (BDC) AND ONE 6X80 ARMADA BDC WERE ADVANCE TO THE TARGET LESION AND ALL THREE BALLOONS RUPTURED AT 6 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. AN UNSPECIFIED 6X80MM 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 23085760 ↗
• MalfunctionSep 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN SUPERFICIAL FEMORAL ARTERY (SFA). TWO 6X200MM ARMADA BALLOON DILATATION CATHETERS (BDC) AND ONE 6X80 ARMADA BDC WERE ADVANCE TO THE TARGET LESION AND ALL THREE BALLOONS RUPTURED AT 6 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. AN UNSPECIFIED 6X80MM 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 23085700 ↗
• MalfunctionSep 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 6 FRENCH (FR) SHEATH WAS ADVANCED AND AN ATHERECTOMY DEVICE WAS USED WITHOUT ISSUES. THE 6.0X200MM ARMADA 35 LL BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE AND ADVANCED WITHOUT RESISTANCE BUT RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATMS). A NON-ABBOTT BALLOON AND STENT 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 23028383 ↗
• MalfunctionOct 18, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 6.0X200MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE CALCIUM. THE RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME SIZE 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 20482477 ↗
• MalfunctionNov 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN AN UNSPECIFIED ARTERY. THE 6X200MM ARMADA 35 WAS PREPPED PER THE INSTRUCTIONS FOR USE AND THERE WERE NO ISSUES DURING ADVANCEMENT. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE ARMADA WAS REMOVED AND AN ATHERECTOMY DEVICE WAS ADVANCED TO SPIN THE CALCIFICATION. THEN, ANOTHER 6MM ARMADA BALLOON WAS ADVANCED AND USED WITHOUT ISSUE. 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 18196892 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. DILATATION WAS PERFORMED USING THE 6.0 X 200 MM ARMADA 35 LL DILATATION CATHETER. AFTER BALLOON INFLATION, AN ANGIO IMAGE WAS ACQUIRED SHOWING A DISSECTION IN THE VESSEL THAT WAS BALLOONED. A BARE METAL STENT WAS PLACED TO TREAT THE DISSECTION. THE CONDITION RESOLVED WITH NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 18171509 ↗
• MalfunctionOct 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS RIGHT SUPERIOR FEMORAL ARTERY (SFA). AN UNSPECIFIED GUIDING CATHETER WAS ADVANCED AND A COMMAND 18 GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED; HOWEVER, BECAME STUCK WITH THE GUIDING CATHETER. IT WAS NOTED THE GUIDING CATHETER HAD BECOME KINKED AND WHERE THE KINK WAS THE COMMAND 18 WAS STUCK. DEVICE COULD NOT BE REMOVED ON ITS OWN THEREFORE, IT WAS REMOVED AS A ONE UNIT. A NEW CATHETER AND UNSPECIFIED GUIDE WIRE WERE USED TO CONTINUE THE PROCEDURE. A 6.0X200MM ARMADA 35 BALLOON WAS ADVANCED; HOWEVER, RUPTURED AT THE TARGET LESION. ANOTHER UNSPECIFIED BALLOON WAS USED TO CONTINUE THE PROCEDURE AND UNSPECIFIED STENTS WERE 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 17881375 ↗
• InjuryAug 8, 2023Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND NO TORTUOSITY. THE 6.0X200MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND INFLATED MULTIPLE TIMES WITH THE 1ST INFLATION AT 4 ATMOSPHERES (ATMS) FOR 10 SEC, 2ND INFLATION AT 12 ATMS FOR 30 SEC, 3RD INFLATION AT 12 ATMS FOR 30 SEC, 4TH INFLATION AT 8 ATMS FOR 30 SEC, 5TH INFLATION 22 ATMS FOR 30 SEC, 5TH INFLATION 30 ATMS FOR 15 SECOND AT WHICH TIME THE BALLOON RUPTURED. BLOOD WAS LEAKING IN THE BALLOON THEREFORE THE BALLOON WAS ATTEMPTED TO BE REMOVED FROM THE ANATOMY, HOWEVER, THE BALLOON BUNCHED UP IN THE SHEATH AND THE BALLOON GOT STUCK. FORCE WAS APPLIED AND THE BALLOON SEPARATED. ABOUT 150MM OF THE BALLOON WAS LEFT IN THE ANATOMY. AN ATTEMPT TO SNARE THE SEPARATED PORTION WAS UNSUCCESSFUL SO THE PATIENT WAS SENT TO SURGERY AND A FEMORAL EXPLORATION WAS PERFORMED ABLE TO REMOVE THE ENTIRE BALLOON FROM THE ANATOMY. A FEMORAL POPLITEAL BYPASS WAS ALSO PERFORMED. THE PATIENT IS STABLE. THERE WAS NO ADVERSE PATIENT SEQUELAE. THERE WAS NO DELAY IN THE PROCEDURE THAT RESULTED IN THE PATIENT GOING INTO SURGERY. NO ADDITIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482568 ↗
• MalfunctionFeb 24, 2023Material Rupture; Material Rupture

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440452 ↗
• MalfunctionJun 3, 2022Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OCCLUDED, MILDLY CALCIFIED, MILDLY TORTUOUS, DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A NON-ABBOTT GUIDE WIRE PASSED THE LESION WITHOUT REPORTED ISSUE AND THE 6.0X200 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED; HOWEVER IT IS UNKNOWN TO WHAT PRESSURE OR HOW MANY TIMES. LEAKAGE WAS NOTED FROM THE CATHETER AND THE BALLOON DID NOT INFLATE AT ALL SO THE ARMADA 35 WAS REMOVED. A NON-ABBOTT BALLOON 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 14595075 ↗
• MalfunctionAug 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS HEAVILY CALCIFIED. THE ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE. THE BALLOON WAS USED SUCCESSFULLY THE FIRST TIME AND WAS FINE. THE SECOND TIME IT WAS USED, THE BALLOON INFLATED TO 6-8 ATMOSPHERES, BUT KEPT LOSING PRESSURE AND THERE WAS A SUSPECTED PINHOLE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ARMADA WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277445 ↗
• MalfunctionJun 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT SUPERFICIAL ARTERY. THE ARMADA BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE BALLOON WAS SIMPLY REMOVED AND REPLACED WITH ANOTHER ARMADA BALLOON OF THE SAME SIZE. 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 12071027 ↗
• InjuryOct 22, 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 NON-CALCIFIED, NON-TORTUOUS ILIAC ARTERY. THE 6.0X200MM ARMADA 35 LL BALLOON WAS INFLATED 2 OR 3 TIMES THEN THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. RESISTANCE WAS FELT DURING THE ATTEMPTED REMOVAL. THE SOURCE OF THE RESISTANCE IS UNKNOWN. EXCESSIVE FORCE WAS APPLIED THEN THE BALLOON SEPARATED. THE SEPARATED DISTAL PORTION OF THE BALLOON WAS REMOVED VIA SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722049 ↗
• MalfunctionMar 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION INT HE COMMON FEMORAL ARTERY TO THE SUPERFICIAL FEMORAL ARTERY. A 6X200MM ARMADA 35 LL BALLOON CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE; HOWEVER, THE BALLOON RUPTURED AT NOMINAL PRESSURE 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 Consequences Or Impact To Patient

  MAUDE report 9824438 ↗
• MalfunctionFeb 19, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THREE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS (5X200MM, 5X20MM, 6X200MM) AND TWO ABSOLUTE PRO SELF-EXPANDING STENT SYSTEMS (SESS) (6X150MM, 6X60MM) WERE RECEIVED BY THE CUSTOMER WITH BLOOD MARKS ON THE OUTSIDE PACKAGING. THE DEVICES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9727405 ↗
• MalfunctionAug 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200 MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8913456 ↗
• MalfunctionMay 21, 2018Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY CALCIFIED, CHRONIC TOTALLY OCCLUDED, LEFT SUPERFICIAL FEMORAL ARTERY (SFA) THE 6.0 X 200 MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS INFLATED BELOW OR AT RATED BURST PRESSURE (RBP) WHEN THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED 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 7530821 ↗
• MalfunctionMar 27, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY THAT DID NOT HAVE ANY TORTUOSITY OR CALCIFICATION. A 6.0 X 200 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED AND DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATMS) DURING ITS FIRST INFLATION. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER 6.0 X 200 MM ARMADA 35 BDC TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 7373630 ↗
• MalfunctionFeb 20, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUPERFICIAL FEMORAL ARTERY. THE 6.0X200 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. THE BALLOON RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. THE BDC WAS REMOVE WITHOUT ISSUE AND ANOTHER 6.0X200 MM ARMADA 35 BDC WAS ADVANCED WITHOUT ISSUE AND IT ALSO RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED BDC 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 Consequences Or Impact To Patient

  MAUDE report 7283428 ↗
• MalfunctionFeb 20, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUPERFICIAL FEMORAL ARTERY. THE 6.0X200 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. THE BALLOON RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. THE BDC WAS REMOVE WITHOUT ISSUE AND ANOTHER 6.0X200 MM ARMADA 35 BDC WAS ADVANCED WITHOUT ISSUE AND IT ALSO RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED BDC 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 Consequences Or Impact To Patient

  MAUDE report 7283401 ↗
• MalfunctionFeb 14, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, HEAVILY CALCIFIED, 75 TO 80% STENOSED, RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X 200 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TO 6 ATMOSPHERES FOR A FEW SECONDS, PRESSURE WAS SLOWLY INCREASED TO 12 ATMOSPHERES AND THE BALLOON RUPTURED. A NEW 5.0 X 200 MM ARMADA 35 PTA CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7272040 ↗