Armada B2060-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648155260), received between Sep 23, 2016 and May 29, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0X40MM ARMADA 35 BALLOON DILATATION CATHETER, A HOLE WAS NOTED ON THE BALLOON. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334221 ↗
• MalfunctionOct 23, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 6.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PULLING NEGATIVE WHEN THE BALLOON KEPT GIVING BUBBLES DURING PREPARATION. THE BALLOON WAS TESTED OUTSIDE THE BODY AND IT WAS NOTED THAT THERE WAS A HOLE IN THE BALLOON. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT 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 20517694 ↗
• MalfunctionSep 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X40 MM ARMADA 35 PTA CATHETER RUPTURED DURING THE FIRST INFLATION AT 8 ATM. THE 6X40 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS OF THE ARMADA 18 PTA CATHETER IDENTIFIED THAT THE BALLOON INNER MEMBER AND TIP AND MARKERS WERE SEPARATED FROM THE DEVICE AND NOT RETURNED. THE ACCOUNT WAS NOT AWARE OF THE SEPARATION. THERE IS THE POTENTIAL THAT SOME MATERIAL REMAINED IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182815 ↗
• MalfunctionFeb 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 6X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, THE BALLOON FAILED TO COMPLETELY INFLATE DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND A LEAK WAS NOTED AT THE HUB OF THE BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A 6X60MM ARMADA 35 BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699253 ↗
• MalfunctionFeb 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6MMX40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND ADVANCED TO THE LESION WITH NO REPORTED ISSUE. THE BALLOON OF THE BDC WAS INFLATED SUCCESSFULLY TO 14 ATMOSPHERES DURING THE FIRST INFLATION; HOWEVER, THE BALLOON RUPTURED ON THE SECOND INFLATION AT 16 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ARMADA BDC. 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 18635673 ↗
• MalfunctionJul 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0X400 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED. ANOTHER 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 17367557 ↗
• MalfunctionApr 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 6X40 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO RATED BURST PRESSURE 14 ATMOSPHERES AND RUPTURED. 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 16714367 ↗
• MalfunctionMar 22, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, STENOSED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 6MMX40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED ONCE TO 3 ATMOSPHERES (ATM); HOWEVER, THE BALLOON WOULD NOT INFLATE ANY FURTHER. THE BDC WAS REMOVED AND RE-INSERTED, THIS TIME IT INFLATED TO THE NOMINAL PRESSURE OF 6 ATM BUT WOULD NOT INFLATE ANY FURTHER. THE BDC WAS REMOVED, WITHOUT ISSUE. THE EXPERIENCED SCRUB TECH NOTED THAT THEBALLOON WAS PERFORMING AS IF THERE WAS A SLOW LEAK OR A PIN HOLE.THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A NON-ABBOTT STENT WAS PLACED, AFTER WHICH A NON-ABBOTT BALLOON WAS USED TO POST-DILATATE AND COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595070 ↗
• MalfunctionFeb 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL, MODERATELY CALCIFIED LESIONS. AN ARMADA 35 BALLOON CATHETER ADVANCED TO THE SFA WITHOUT ISSUES. ON THE 1ST INFLATION AT 6 ATMOSPHERES (ATMS), THE BALLOON BURST. AN ARMADA 14 ADVANCED TO THE POPLITEAL WITHOUT ISSUES. ALSO, ON THE 1ST INFLATION AT 6 ATMS, THE BALLOON BURST. BOTH DEVICES WERE REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13431600 ↗
• InjuryJan 7, 2022Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Off-Label Use; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PATIENT CAME IN DUE TO A STROKE AND THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED VESSEL IN THE LEFT CAROTID ARTERY. PRE-DILATATION WAS PERFORMED WITH A 4.0X40MM ARMADA BALLOON WITHOUT ISSUE. THROMBECTOMY WAS PERFORMED. THE 6.0X40MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. THERE WAS NO RESISTANCE DURING ADVANCEMENT THROUGH A TELESCOPING CATHETER. HOWEVER, THE ARMADA WAS INFLATED ONCE TO NOMINAL PRESSURE AND THE BALLOON RUPTURED. IT WAS NOTED THAT WHEN REMOVING THE BALLOON, THERE WAS RESISTANCE NOTED AS THE BALLOON WOULD NOT PULL BACK INTO THE CATHETER. THE BALLOON AND CATHETER WERE THEN PROCEEDED TO BE PULLED OUT TOGETHER. THE PATIENT HAD PRIOR STENTS IN THE ILIACS. THERE WAS RESISTANCE FELT AS THE BALLOON WAS BEING PULLED OUT THROUGH THE ILIACS AND THE TIP SEPARATED. THE TIP WAS LEFT IN THE PATIENT FREE FLOATING IN THE AORTA AROUND THE LEVEL OF THE RENAL ARTERY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13192123 ↗
• MalfunctionJun 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6X40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. A SAME SIZED ARMADA 35 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 12093240 ↗
• MalfunctionMay 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED RIGHT COMMON ILIAC ARTERY. A 6.0X60MM AND A 6.0X40MM ARMADA 35 BALLOON WERE ATTEMPTED TO PRE-DILATE THE LESION; HOWEVER, BOTH BALLOONS REPORTEDLY RUPTURED AT 4 ATMOSPHERES (ATM). BOTH DEVICES WERE REMOVED WITHOUT ISSUE AND A 7.0X59MM OMNILINK STENT WAS IMPLANTED AND A 9.0X60MM ARMADA'S 35 WAS ATTEMPTED TO POST DILATE, BUT RUPTURED AT 6 ATM. 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 11886045 ↗
• MalfunctionApr 5, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE SUBCLAVIAN, HEAVILY CALCIFIED LESION. DURING INFLATION ATTEMPT, LEAKING WAS OBSERVED OUT OF THE HUB AND THE BALLOON FAILED TO INFLATE. ANOTHER DEVICE 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 11613814 ↗
• MalfunctionFeb 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT EXTERNAL ILIAC ARTERY. A STENT HAD BEEN PREVIOUSLY IMPLANTED AT AN UNKNOWN DATE. THE IMPLANTED STENT WAS NOTED TO BE FRACTURED, AND WHEN THE 6.0MM X 40MM X 135CM ARMADA 35 BALLOON DILATATION CATHETER WAS BEING INFLATED, THE FRACTURED STENT RUPTURED THE BALLOON WHEN THE BALLOON WAS JUST UNDER 4 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE AND A NEW ARMADA WAS USED. A NEW STENT WAS IMPLANTED, COMPLETING 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 11382813 ↗
• MalfunctionJan 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, NON-TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. A 6X40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS PREPPED WITHOUT ISSUES AND ADVANCED WITHOUT RESISTANCE. THE BALLOON WAS INFLATED ONCE TO 16 ATMOSPHERES WHEN THE BALLOON RUPTURED, SO THE PTA WAS REMOVED. A SAME SIZED ARMADA 35 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 11127156 ↗
• MalfunctionNov 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DURING DEVICE PREPARATION OF THE ARMADA 35 DILATATION CATHETER, THE DEVICE WAS NOTED TO PULL AIR AND WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10814383 ↗
• MalfunctionAug 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 40% STENOSED AND NON-TORTUOUS, NON-CALCIFIED LESION IN THE CEPHALIC VEIN. A 6X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 6X60MM ARMADA 35 BDC. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8942542 ↗
• MalfunctionJul 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6 X 40 MM ARMADA 35 BALLOON RUPTURED AT 5 ATMOSPHERES DURING INFLATION. NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7675722 ↗
• MalfunctionJan 3, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. WHEN PRESSURIZING THE 6 X 40 MM ARMADA 35 BALLOON CATHETER IT RUPTURED DURING THE FIRST INFLATION AT RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162371 ↗
• MalfunctionFeb 14, 2017Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT COMMON ILIAC. WHEN ATTEMPTING TO INFLATE THE ARMADA 35 BALLOON CATHETER, CONTRAST WAS NOTED TO BE LEAKING FROM THE DEVICE, ALTHOUGH LOCATION FROM WHERE IT WAS LEAKING IS UNKNOWN. THE DEVICE WAS REMOVED AND ANOTHER ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO RESISTANCE DURING THE REMOVAL OF THE PROTECTIVE SHEATH OR DURING ADVANCEMENT TO THE LESION. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. 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 6329440 ↗
• MalfunctionOct 25, 2016Detachment Of Device Component; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED LEFT EXTERNAL ILIAC. A 6.0 X 40 MM ARMADA 35 CATHETER WAS BEING USED FOR PRE-DILATATION AND WAS INFLATED 3 TIMES TO 6 ATMOSPHERES AND THEN PRESSURIZED TO 9 ATMOSPHERES WHEN THE BALLOON RUPTURED AND SEPARATED INTO TWO PIECES. THE ENTIRE SYSTEM: SHEATH, GUIDE WIRE AND BALLOON CATHETER, WITH THE SEPARATED PIECE INCLUDED, WAS REMOVED FROM THE ANATOMY AS A SINGLE UNIT. AN ASAHI PROWATER 300 GUIDE WIRE WAS BEING USED IN THE PROCEDURE AND AFTER REMOVAL FROM THE ANATOMY, IT WAS FOUND THAT THE COILS WERE STRETCHED OUT. THERE WAS NO RESISTANCE REPORTED. A NEW SHEATH WAS PLACED AND AN UNSPECIFIED STENT WAS DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6055500 ↗
• MalfunctionOct 4, 2016Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDY TORTUOUS, MILDLY CALCIFIED, SUPERFICIAL FEMORAL ARTERY (SFA), THE ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED FOR LESION PRE-DILATATION AT 8 ATMOSPHERE (ATM) WHEN IT RUPTURED. 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 5998277 ↗
• MalfunctionSep 23, 2016Material Rupture

  IT WAS REPORTED THAT DURING PRE-DILATATION IN A PROCEDURE OF THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) THE ARMADA 35 BALLOON RUPTURED BELOW RATED BURST PRESSURE (RBP). THERE WAS NO REPORTED RESISTANCE DURING ADVANCING OR DURING REMOVAL OF THE DEVICE. THE DEVICE WAS REMOVED AND A DIFFERENT DEVICE USED IN THE PROCEDURE. 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 5973488 ↗