XXL™ Esophageal M001145590Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 08714729163190), received between Aug 23, 2018 and Feb 20, 2026 — classified as 4 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (105 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 18-6/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 5 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405203 ↗
• MalfunctionFeb 20, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 18-6/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 5 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405043 ↗
• InjuryMar 27, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON RUPTURED DURING THE PROCEDURE, WAS DIFFICULT TO REMOVE AND SUBSEQUENTLY DISLODGED, REQUIRING INTERVENTION. THE PATIENT WAS BEING TREATED FOR SWELLING OF BILATERAL (B/L) LEGS. AFTER OBTAINING B/L POPLITEAL ACCESS WITH 10FR SHEATHS, 035 AMPLATZ GUIDEWIRES WERE INSERTED B/L, FOLLOWED BY INTRAVASCULAR ULTRASOUND (IVUS) WHICH REVEALED 61% INFERIOR VENA CAVA (IVC) HYPERPLASIA, APPROXIMATELY 40% B/L COMMON ILIAC VEIN (CIV) HYPERPLASIA, 64% RIGHT EXTERNAL ILIAC VEIN (EIV) HYPERPLASIA, 11% LEFT EIV HYPERPLASIA, 16% RIGHT COMMON FEMORAL VEIN (CFV) HYPERPLASIA, AND 60% LEFT CFV HYPERPLASIA. AN 18X60 WALLSTENT WAS PLACED IN THE MILDLY TORTUOUS LEFT COMMON FEMORAL VEIN (CFV) AND B/L 16X120 NON-BOSTON SCIENTIFIC (BSC) STENTS WERE PLACED IN THE IVC TO CIV. TWO 16X6 XXL ESOPHAGEAL BALLOONS WERE USED TO POST DILATE BOTH SIDES SIMULTANEOUSLY AT 5 ATMOSPHERES WITH NO DIFFICULTIES AND BOTH BALLOONS WERE REMOVED INTACT. POST DILATATION OF THE STENTS WAS PERFORMED WITH TWO 18-6/5.8/75 XXL ESOPHAGEAL BALLOONS WHICH WERE SIMULTANEOUSLY INFLATED AT 5 ATMOSPHERES WITH MULTIPLE INFLATIONS. DURING THE LAST INFLATION AT THE PROXIMAL ENDS OF THE STENTS WITH BALLOONS OUTSIDE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712804 ↗
• MalfunctionDec 6, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. DURING THIS VENOGRAM PROCEDURE, VASCULAR ACCESS WAS OBTAINED VIA POPLITEAL BILATERAL APPROACH WITH AN AMPLATZ GUIDEWIRE. DURING THE PROCEDURE, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND FOUND 72% COMPRESSION IN THE LEFT COMMON ILIAC VEIN (CIV) AND 54% IN THE RIGHT CIV. TWO 20X80 WALLSTENT SELF-EXPANDING STENTS WERE PLACED AND POST DILATED WITH A 16X16 XXL ESOPHAGEAL BALLOON CATHETER. THEN IVUS WAS PERFORMED AGAIN AND NOTED THAT THE STENTS WERE UNDER EXPANDED IN THE PROXIMAL CIVS. THEREFORE, AN 18-6/5.8/75 XXL ESOPHAGEAL BALLOON WAS INSERTED FOR DILATION. UPON INSERTION, BLOOD RETURNED TO THE INFLATION DEVICE WITHOUT INFLATING THIS BALLOON. THE DEVICE WAS REPLACED WITH ANOTHER 18X6 XXL BALLOON AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864549 ↗
• MalfunctionMay 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. PATIENT BEING TREATED FOR MAY THURNER. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHEN NEGATIVE PRESSURE WAS APPLIED, IT WAS NOTED THAT THE BALLOON RETURN COMING BACK TO THE INDEFLATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322889 ↗
• MalfunctionMar 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 78% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC VEIN. TWO 18-6/5.8/75 XXL ESOPHAGEAL WERE ADVANCED BILATERAL FOR KISSING BALLOON DILATATION. HOWEVER, DURING FIRST SIMULTANEOUS INFLATION AT 5 ATMOSPHERES FOR 5 SECONDS, THE BALLOON BURST. UPON DEFLATION, IT WAS NOTED THAT THE BLOOD RETURNED TO BOTH IN DEFLATORS AND BURST WAS CONFIRMED. BOTH BALLOONS WERE REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992921 ↗
• MalfunctionMar 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 78% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC VEIN. TWO 18-6/5.8/75 XXL ESOPHAGEAL WERE ADVANCED BILATERAL FOR KISSING BALLOON DILATATION. HOWEVER, DURING FIRST SIMULTANEOUS INFLATION AT 5 ATMOSPHERES FOR 5 SECONDS, THE BALLOON BURST. UPON DEFLATION, IT WAS NOTED THAT THE BLOOD RETURNED TO BOTH IN DEFLATORS AND BURST WAS CONFIRMED. BOTH BALLOONS WERE REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992903 ↗
• MalfunctionMar 28, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. PATIENT UNDERWENT A VENOGRAM PROCEDURE WHERE THE PHYSICIAN OBTAINED VENOUS ACCESS AND DID AN INITIAL INTERVASCULAR ULTRASOUND RUN. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED COMMON FEMORAL ARTERY. AN 18X90X75CM VENOUS WALLSTENT WAS IMPLANTED, BUT IT WAS NOTED THAT THE DISTAL TIP WAS NOT EXPANDING. AN 18-6/5.8/75 XXL ESOPHAGEAL BALLOON DILATOR WAS ADVANCED FOR DILATION, BUT IT WOULD NOT TRACK THROUGH THE DISTAL PORTION OF THE STENT. A SMALLER 035 NON-BOSTON SCIENTIFIC BALLOON WAS SWITCHED WHICH SUCCESSFULLY TRACKED AND EXPANDED. THE FLOW POST-STENT WAS UNSATISFACTORY AFTER SHOOTING CONTRAST ON FLUOROSCOPY. THE PHYSICIAN MADE FURTHER ACCESS BY FIRST INSERTING THE NON-BSC BALLOON FOLLOWED BY THE XXL BALLOON. ON THE SECOND INFLATION, THE XXL BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED BY A DIFFERENT MODEL TO COMPLETE THE PROCEDURE. THE WALLSTENT FULLY EXPANDED IN WHICH THE CASE ENDED WITH A GOOD FLOW. THE STENT STRUTS WERE ASSUMED TO BE STUCK TOGETHER, BUT AFTER REVIEWING POST-CASE, THEY MAY HAVE INITIALLY STUCK AND STENTED THE TIP OF THE GREAT SAPHENOUS VEIN INSTEAD OF THE COMMON FEMORAL ARTERY IN WHICH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991236 ↗
• MalfunctionMar 20, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-FEB-2024. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND SEVERELY CALCIFIED VESSEL. DURING THE PROCEDURE, AFTER 8X90 VENOUS WALLSTENTS WERE PLACED, A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED INTO BILATERAL BIFURCATION COMPRESSION AND ANOTHER 18-6/5.8/75 XXL ESOPHAGEAL BALLOON ADVANCED INTO THE BILATERAL COMMON ILIAC VEIN (CIV) COMPRESSION. BOTH BALLOONS WERE PLACED JUST BELOW THE PROXIMAL PART OF THE STENTS AND THE PHYSICIAN STARTED THE KISSING BALLOON TECHNIQUE, BUT NEITHER BALLOONS WOULD REACH 5 ATMOSPHERES. A BALLOON LEAK WAS NOTED. THE BALLOONS WERE REPLACED, AND THE CASE WAS FINISHED SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946589 ↗
• MalfunctionMar 20, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-FEB-2024. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND SEVERELY CALCIFIED VESSEL. DURING THE PROCEDURE, AFTER 8X90 VENOUS WALLSTENTS WERE PLACED, A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED INTO BILATERAL BIFURCATION COMPRESSION AND ANOTHER 18-6/5.8/75 XXL ESOPHAGEAL BALLOON ADVANCED INTO THE BILATERAL COMMON ILIAC VEIN (CIV) COMPRESSION. BOTH BALLOONS WERE PLACED JUST BELOW THE PROXIMAL PART OF THE STENTS AND THE PHYSICIAN STARTED THE KISSING BALLOON TECHNIQUE, BUT NEITHER BALLOONS WOULD REACH 5 ATMOSPHERES. A BALLOON LEAK WAS NOTED. THE BALLOONS WERE REPLACED, AND THE CASE WAS FINISHED SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946588 ↗
• MalfunctionFeb 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT A VENOUS STENTING. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED BILATERAL COMMON ILIAC VEIN/CONFLUENCE. AN 8-6/5.8/75 XXL BALLOON DILATOR WAS ADVANCED; HOWEVER, DURING THE FIRST INFLATION AT 5 ATMOSPHERES JUST TO GET WALL APPOSITION, THE MID BALLOON BURST. ANOTHER OF THE SAME MODEL WAS USED, BUT IT HAD ALSO BURST THE EXACT SAME WAS WHICH WAS ON THE FIRST INFLATION, 5 ATMOSPHERES, TOWARDS THE WALL APPOSITION, MID BALLOON. BOTH DEVICES WERE REMOVED INTACT OVER THE WIRE WITHOUT SEPARATING THE BALLOONS, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743940 ↗
• MalfunctionFeb 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT A VENOUS STENTING. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED BILATERAL COMMON ILIAC VEIN/CONFLUENCE. AN 8-6/5.8/75 XXL BALLOON DILATOR WAS ADVANCED; HOWEVER, DURING THE FIRST INFLATION AT 5 ATMOSPHERES JUST TO GET WALL APPOSITION, THE MID BALLOON BURST. ANOTHER OF THE SAME MODEL WAS USED, BUT IT HAD ALSO BURST THE EXACT SAME WAS WHICH WAS ON THE FIRST INFLATION, 5 ATMOSPHERES, TOWARDS THE WALL APPOSITION, MID BALLOON. BOTH DEVICES WERE REMOVED INTACT OVER THE WIRE WITHOUT SEPARATING THE BALLOONS, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743939 ↗
• MalfunctionJun 29, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON DEFLATED SLOWLY. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED AND USED FOR DILATATION. UPON COMPLETION, IT WAS NOTED THAT DEFLATION OF THE BALLOON WAS TOO SLOW. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232310 ↗
• MalfunctionJun 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT SUFFERING FROM CHRONIC VENOUS INSUFFICIENCY. THE 40% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED COMMON FEMORAL ILIAC VEIN. AFTER STENTING WITH WALLSTENT, POST-DILATION WAS PERFORMED WITH A 18-6/5.8/75 XXL BALLOON CATHETER. HOWEVER, DURING INFLATION AT 2 ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226397 ↗
• InjuryApr 6, 2023Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE, DETACHMENT AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT WAS BEING TREATED FOR VENOUS COMPRESSION. THE 50% OR GREATER STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT COMMON ILIAC ARTERY. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED TO POST-DILATE THE FULLY DEPLOYED 20 X 80 X 75CM VENOUS WALLSTENT. HOWEVER, DURING THE SECOND INFLATION AT 5 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED DUE TO CONTACT WITH THE WALLSTENT STRUTS. DIFFICULTY REMOVING THE BALLOON THROUGH THE SHEATH WERE ENCOUNTERED. EVENTUALLY, A NON-BSC DEVICE WAS USED TO SNARE IN ORDER TO RETRIEVE AND REMOVED SUCCESSFULLY THE EXCESS BALLOON THAT LODGED IN THE POPLITEAL VEIN OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS NOTED THAT PATIENT MIGHT DEVELOPED A HEMATOMA. THE PATIENT CONDITION WAS GOOD POST-PROCEDURE AND FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688820 ↗
• MalfunctionFeb 3, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION SLOW OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ESOPHAGEAL. THE PATIENT UNDERWENT ESOPHAGEAL BALLOONING. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING DEFLATION, THE DEFLATION TIME TOOK MORE THAN 50 SECONDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292508 ↗
• MalfunctionJan 23, 2023Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT BALLOON SHAFT PERFORATION OCCURRED. THE PATIENT PRESENTED WITH ILIAC VEIN STENOSIS AND UNDERWENT STENTING. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING INFLATION, BLOOD LEAKAGE WAS FOUND INSIDE THE BALLOON AND WAS NOTED TO BE PERFORATED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229964 ↗
• MalfunctionJan 23, 2023Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS BEING TREATED FOR TIBIAL STENOSIS. THE TARGET LESION WAS LOCATED IN THE ILIAC VESSEL. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING UNPACKING, IT WAS FOUND THAT THE CATHETER WAS BROKEN AND NOT SUITABLE FOR USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229563 ↗
• MalfunctionJan 4, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS SLOW TO DEFLATE. THE PATIENT PRESENTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE ILIAC VEIN. A 18-6/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS TOO SLOW TO DEFLATE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099439 ↗
• MalfunctionNov 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TO MODERATELY TORTUOUS VESSEL. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 4 ATMOSPHERES FOR 10-15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH 18X6 XXL ESOPHAGEAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15773839 ↗
• InjurySep 7, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON DETACHMENT OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT COMMON ILIAC VEIN. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING REMOVAL, IT WAS HARD TO REMOVE FROM A NON-BSC SHEATH. WHEN PULLED HARDER, IT WAS NOTED THAT THE BALLOON MATERIAL WAS DETACHED FROM THE CATHETER AND DISLODGED IN THE SHEATH. THE SHEATH WAS REMOVED OVER THE WIRE AND THE DETACHED COMPONENT WAS RETRIEVED WITH HEMOSTAT CLAMP IN THE PATIENT SOFT TISSUE TRACT BELOW THE SHEATH. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370619 ↗
• MalfunctionSep 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH LEG SWELLING AND UNDERWENT VENOGRAM WITH BILATERAL STENT AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS RIGHT COMMON ILIAC VEIN (RCIV). AFTER DEPLOYING A 18X90 STENT AND A18X60 STENT, A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 3 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347698 ↗
• InjuryJul 22, 2022Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE, DIFFICULTY REMOVAL, AND A BALLOON BREAK OCCURRED REQUIRING SURGICAL INTERVENTION. THE 70% STENOSED TARGET LESION WAS LOCATED IN RIGHT COMMON ILIAC VEIN. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING FOURTH INFLATION AT 2 ATMOSPHERES FOR 3 MINUTES, THE BALLOON RUPTURED. DURING REMOVAL OF THE BALLOON OVER A 0.035 GUIDEWIRE, THE DISTAL HALF OF THE BALLOON BROKE AND WAS STUCK INSIDE THE LESION. THE REMAINING PORTION OF THE BALLOON WAS SUCCESSFULLY REMOVED. A SNARE WAS USED TO REMOVE THE REST OF THE BALLOON FROM THE PATIENT, BUT WAS UNSUCCESSFUL. THE PATIENT WAS STABLE AND SENT TO THE HOSPITAL TO SURGICALLY REMOVE THE REST OF THE BALLOON.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 15085115 ↗
• MalfunctionApr 6, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 5 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14031136 ↗
• MalfunctionApr 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MILD TO MODERATELY TORTUOUS ILIAC VEIN. AN 18-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017950 ↗