Armada B1100-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08717648154942), received between Jan 24, 2017 and Nov 5, 2025 — classified as 9 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2025, TO TREAT AN ARTERIOVENOUS FISTULA IN THE LEFT ARM. THE 10X40MM ARMADA 35 BALLOON DILATATION CATHETER, WAS ADVANCED TO THE STENOSED LESION AND INFLATED. AFTER THE SECOND INFLATION TO AN UNKNOWN PRESSURE, THE BALLOON RUPTURED. DURING REMOVAL, RESISTANCE WAS FELT AND THE DISTAL TIP SEPARATED AND REMAINED IN THE PATIENT. AN ATTEMPT WAS MADE TO SNARE OUT THE SEPARATED TIP BUT IT COULD NOT BE REMOVED. ON (B)(6) 2025, A FULL CUT-DOWN WAS REMOVED TO REMOVE THE SEPARATED TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479866 ↗
• InjuryJun 11, 2025Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE AV FISTULA. THE 10X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 20 ATMOSPHERES (ATM). THE BDC WAS REMOVED FROM THE PATIENT; HOWEVER, FRAGMENTS OF THE BALLOON REMAINED IN THE PATIENT. THEREFORE, A SNARE WAS USED TO REMOVE THE BALLOON FRAGMENTS. ANOTHER ARMADA BALLOON WAS USED TO THE CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186378 ↗
• InjuryMay 28, 2025Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS RIGHT CEPHALIC VEIN THAT IS 70% STENOSED. THE 10X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS USED IN THE SUBCLAVIAN VEIN AT NOMINAL PRESSURE THREE TIMES THEN IN THE CEPHALIC VEIN RUPTURING AS IT WAS INFLATED TO 17-18 ATMOSPHERES. IT WAS NOTED THAT THE VESSEL HAD ALREADY BEEN TREATED WITH AN 8X40MM ARMADA WITH NO RESIDUAL WAIST. DURING REMOVAL, RESISTANCE WAS FELT AS PART OF THE BALLOON HAD SEPARATED WHEN ATTEMPTING TO REMOVE THROUGH THE 8FR SHEATH IN RIGHT UPPER ARM; THEREFORE, THE WIRE WAS SNARED FROM THE GROIN ACCESS AND BALLOON REMOVED VIA 16FR SHEATH. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER, CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097729 ↗
• InjuryJan 22, 2025Material Rupture; Material Separation; Difficult to Advance; Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY TORTUOUS, ARTERIOVENOUS FISTULA IN THE LEFT CEPHALIC ARCH THAT IS SEVERELY STENOSED. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE 10X40MM ARMADA 35 DUE TO ANATOMY. DURING THE FIRST INFLATION AT 12 ATMOSPHERES THE BALLOON RUPTURED AND SEPARATED. THE SEPARATED PORTION WAS RETRIEVED VIA SNARE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE 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 21211615 ↗
• MalfunctionJan 8, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE COMMON ILIAC ARTERY. THE 10.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. 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 21102264 ↗
• MalfunctionOct 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY WITH CALCIFICATION. THE 10X40MM ARMADA35 BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION; HOWEVER, THE BDC RUPTURED AT NOMINAL PRESSURE AFTER THE SECOND INFLATION. THE BDC WAS REMOVED FROM THE PATIENT AND A 10X20MM ARMADA BALLOON 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 20385963 ↗
• MalfunctionOct 30, 2023Inflation Problem; Material Separation; Inflation Problem; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE COMMON ILIAC ARTERY. THE 10X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATION OF A STENT GRAFT; HOWEVER, THE BALLOON FAILED TO INFLATE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND THE BALLOON WAS NOTED TO BE SEPARATED. IT WAS CONFIRMED THAT THE SEPARATED BALLOON WAS REMOVED WITH THE BDC. ANOTHER SAME SIZE ARMADA WAS USED TO COMPLETE 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 18029986 ↗
• MalfunctionOct 18, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON ILIAC ARTERY WITH 99% STENOSIS AND HEAVY CALCIFICATION. THE 10.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY AND RUPTURED DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATMS). THE DEVICE WAS SOAKED AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. A NON-ABBOTT DEVICE WAS USED TO DILATE THE LESION WHICH WAS FOLLOWED BY STENT DEPLOYMENT 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 15628748 ↗
• MalfunctionSep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO COMMON ILIAC ARTERY. FOR PRE-DILATATION, A 10X40MM ARMADA 35 BALLOON WAS ADVANCED AND INFLATED BUT WAS NOTED AS RUPTURED. NO RESISTANCE MET DURING ADVANCEMENT TO THE LESION. ARMADA 35 WAS REMOVED FROM THE ANATOMY AND REPLACED WITH ANOTHER SAME SIZE ARMADA TO COMPLETE THE PROCEDURE. PHYSICIAN BELIEVES THE BALLOON WAS POSSIBLY DAMAGED IN THE FIRST PLACE, BUT UNABLE TO CONFIRM. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412835 ↗
• MalfunctionFeb 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MILDLY CALCIFIED, 90% STENOSED, MILDLY TORTUOUS RIGHT COMMON ILIAC ARTERY. AN ARMADA 35 WAS ADVANCED TO THE LESION. DURING THE FIRST INFLATION TO 10 ATMOSPHERES, THE BALLOON RUPTURED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581903 ↗
• MalfunctionOct 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION. A NON-ABBOTT COVERED STENT (ICAST) WAS PLACED WITH POSSIBLE STENT DAMAGE DUE TO THE EXTREME CALCIFICATION. FOR POST-DILATATION, AN ARMADA BALLOON CATHETER ADVANCED WITHOUT ISSUE. DURING DILATATION, THE BALLOON RUPTURED AT 11 ATMOSPHERES. THE DEVICE WAS REMOVED, AND ANOTHER ARMADA WAS SUCCESSFULLY USED IN REPLACEMENT. THE BALLOON RUPTURE WAS THOUGHT TO BE FROM THE NON-ABBOTT COVERED STENT DAMAGE. THERE WAS NO ADVERSE PATIENT EFFECT 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 12579947 ↗
• MalfunctionSep 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE ILIAC VEIN. THE 10X40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER BALLOON WAS USED FOR POST DILATATION AFTER ILIAC VEIN STENTING AND WAS INFLATED TWICE AT 10 ATMOSPHERES (ATMS). THE BALLOON RUPTURED ON THE SECOND INFLATION. ANOTHER SAME SIZE ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532942 ↗
• InjuryMay 17, 2021Entrapment of Device; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT EXTERNAL ILIAC ARTERY. A 10X40MM ARMADA 35 BALLOON WAS NOT AIR ASPIRATED OUTSIDE OF THE ANATOMY PRIOR TO USE. THE DEVICE WAS ADVANCED TO THE LESION WITHOUT ISSUE. THE BALLOON WAS INFLATED ONCE BUT RUPTURED AT 2-3 ATMOSPHERES. WHEN ATTEMPTING TO REMOVE THE BALLOON IT BECAME STUCK ON THE SHEATH AND GUIDE WIRE AND WOULD NOT COME OUT. THE BALLOON WAS PULLED AGAINST RESISTANCE WITH EXTRA FORCE WHICH CONSEQUENTLY SEPARATED THE BALLOON PORTION IN TWO PIECES (BETWEEN THE RADIO-OPAQUE MARKERS). THIS THEN REQUIRED A CUT-DOWN SURGERY TO RETRIEVE ALL OF THE PARTS AND CONTINUE WITH THE PLANNED SURGERY. ALL PORTIONS OF THE DEVICE WERE SUCCESSFULLY RETRIEVED. THERE WAS A CLINICALLY SIGNIFICANT DELAY NOTED AS THE PROCEDURE WAS PROLONGED WITH ADDITIONAL ANESTHESIA USED . SUBSEQUENT TO THE INITIALLY FILED MDR, THE ACCOUNT CONFIRMED THERE WAS HEAVY CALCIFICATION NEAR THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11837684 ↗
• MalfunctionMar 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUBCLAVIAN ARTERY-TO-INNOMINATE VEIN FISTULA LESION THAT WAS MILDLY CALCIFIED AND 70% STENOSED. THE ARMADA BALLOON CATHETER WAS PREPARED PER INSTRUCTIONS FOR USE (IFU). AFTER DEVICE PREPARATION, THE BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING THE FIRST INFLATION AT 10-12 ATMOSPHERES, THE BALLOON RUPTURED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT NON-COMPLIANT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555192 ↗
• InjuryFeb 25, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 70% RE-STENOSED STENT IN THE INTERNAL ILIAC ARTERY. THE ARMADA 35 WAS PREPARED PER THE IFU AND ADVANCED TO THE LESION, WITHOUT ISSUE, VIA LEFT GROIN ACCESS WITH AN 8F SHEATH. THE BALLOON RUPTURED ON ITS 1ST INFLATION AT 8 ATMOSPHERES (ATM) AND THE DEVICE WAS REMOVED, WITHOUT ISSUE; HOWEVER, IT WAS NOTED THAT THE DISTAL TIP OF THE BALLOON HAD SEPARATED COMPLETELY AND WAS TRAPPED UP AGAINST THE PREVIOUS IMPLANTED STENT AND SEVERE CALCIUM. AN ATTEMPT WAS MADE TO SNARE THE SEPARATED TIP, BUT IT WAS UNSUCCESSFUL. TWO OMINI LINK STENTS WERE THEN ADVANCED , KISSING STENT TECHNIQUE, INTO THE DISTAL AORTA, TO EMBED THE TIP OF THE BALLOON INTO THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11383148 ↗
• MalfunctionDec 3, 2020Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SHUNT WITH CALCIFIED STENOSIS. THE ARMADA 35 WAS ADVANCED AND DURING THE FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED RADIALLY AROUND THE SHOULDER OF THE BALLOON AND WAS IN TWO PIECES. THE BALLOON PIECES, WIRE AND SHEATH WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY. THE SHUNT WAS RE-ACCESSED AND THE PROCEDURE COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10939141 ↗
• MalfunctionApr 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, NON-TORTUOUS VENOUS FISTULA. THE 10X40MM ARMADA 35 BALLOON RUPTURED AT THE RATED BURST PRESSURE ON THE FIRST INFLATION. THE DEVICE WAS REPLACED WITH A NEW UNSPECIFIED DEVICE 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 9960275 ↗
• MalfunctionDec 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, NON-TORTUOUS CEPHALIC ARCH. THE 10X40MM ARMADA 35 BALLOON RUPTURED AT 10 ATMOSPHERES ON THE FIRST INFLATION. A NEW SAME BALLOON WAS USED AND IT RUPTURED AT 12 ATMOSPHERES ON THE FIRST INFLATION. A NEW NON-ABBOTT HIGH PRESSURE NC 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 Consequences Or Impact To Patient

  MAUDE report 9433748 ↗
• MalfunctionDec 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, NON-TORTUOUS CEPHALIC ARCH. THE 10X40MM ARMADA 35 BALLOON RUPTURED AT 10 ATMOSPHERES ON THE FIRST INFLATION. A NEW SAME BALLOON WAS USED AND IT RUPTURED AT 12 ATMOSPHERES ON THE FIRST INFLATION. A NEW NON-ABBOTT HIGH PRESSURE NC 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 Consequences Or Impact To Patient

  MAUDE report 9433696 ↗
• MalfunctionMay 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED UNSPECIFIED GRAFT LESION. DURING USE OF A 10X40MM ARMADA 35 BALLOON DILATATION CATHETER, THE BALLOON RUPTURED AT FIRST INFLATION AT 12 ATMOSPHERES. AN UNSPECIFIED NON-ABBOTT 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 Consequences Or Impact To Patient

  MAUDE report 8596588 ↗
• MalfunctionOct 3, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE COMMON ILIAC ARTERY. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED TO THE LESION AND A 10 X 40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE GUIDE WIRE, INSIDE THE ANATOMY. HOWEVER, WHEN CONNECTING THE HUB OF THE DEVICE TO A MANOMETER, A CRACK WAS NOTED ON THE HUB. ADDITIONALLY, A LEAK WAS NOTED TO BE COMING FROM THE HUB. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER 10 X 40 MM ARMADA 35 BDC 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 Consequences Or Impact To Patient

  MAUDE report 7931475 ↗
• MalfunctionSep 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA. A 10X40MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE, HOWEVER DURING THE FIRST INFLATION TO 4 ATMOSPHERES (ATM), THE BALLOON RUPTURED. A SECOND 10X40MMX135CM ARMADA 35 BDC ALSO RUPTURED AT 4 ATM. A 10X40MMX80CM ARMADA 35 BDC RUPTURED AT 6 ATM, AND A 12X40MMX80CM ARMADA 35 BDC, RUPTURED AT 4 ATM. ALTHOUGH NO DAMAGE WAS SEEN ON THE INDEFLATOR, IT WAS STATED THERE COULD BE AN ISSUE WITH THE INDEFLATOR, SINCE THE FOUR BALLOONS RUPTURED DURING INFLATION WITH THE SAME INDEFLATOR. A NEW INDEFLATOR AND AN UNSPECIFIED BDC WERE USED WITHOUT FURTHER ISSUES 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 7847475 ↗
• MalfunctionMay 14, 2018Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 10X40 MM ARMADA 35 DILATATION CATHETER WAS ADVANCED TO THE MODERATELY CALCIFIED CENTRAL VEIN AND INFLATED. THE BALLOON RUPTURED AT 11 BARS OF PRESSURE WITH THE FIRST INFLATION. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513196 ↗
• InjuryMay 11, 2018Detachment Of Device Component; Inflation Problem; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE ECCENTRIC, MODERATELY CALCIFIED, RESTENOSED, SHUNT IN THE LOWER ARM AREA, A NON-ABBOTT GUIDE WIRE AND 6 FR NON-ABBOTT SHEATH WERE POSITIONED. THE 10-X40X80 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED TO UNDER RATED BURST PRESSURE (RBP). AT SOME POINT, THE BALLOON INFLATED IN A DUMB-BELL-LIKE SHAPE. DURING THE THIRD INFLATION, THE BALLOON RUPTURED. THE LESION WAS FULLY EXPANDED. AS THE BDC WAS BEING REMOVED, RESISTANCE WAS MET AND THE BDC CAUGHT IN THE DISTAL PART OF THE SHEATH. THE BDC WAS FORCEFULLY PULLED AND THE DEVICE SEPARATED. THE PROXIMAL SHAFT AND HALF OF THE BALLOON WERE REMOVED. THE DISTAL FRAGMENT REMAINED IN THE ANATOMY. SURGICAL CUTDOWN WAS USED TO REMOVE THE BALLOON FRAGMENT. THE PROCEDURE WAS PROLONGED, BUT THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508182 ↗
• MalfunctionJan 26, 2018Detachment Of Device Component; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CLOT IN THE RIGHT FEMORAL / RIGHT COMMON ILIAC VEIN. CATHETER ASSISTED THROMBOLYSIS (EKOS) WAS USED. POST EKOS, AN ARMADA 35 10 MM / 40 MM BALLOON WAS ADVANCED FROM FEMORAL TO ILIAC VEIN. THE ARMADA WAS INFLATED TWICE AND RUPTURED AT 12 ATMOSPHERES NEAR THE PREVIOUSLY IMPLANTED STENTS IN THE ILIAC VEIN. ANGIOGRAPHY SHOWED THE DISTAL END OF THE BALLOON WAS KNOTTED AND STUCK ON THE GUIDE WIRE AND HALF THE BALLOON WAS IN THE GUIDING CATHETER. THE KNOTTED PORTION OF THE BALLOON THAT WAS STUCK ON THE GUIDE WIRE WAS EVENTUALLY SAFELY REMOVED WHEN THE SHEATH WAS UPSIZED TO A 14 FRENCH. NOTHING WAS EVER FREE-FLOATING. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT IN THE ANATOMY. 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 7223353 ↗