XXL™ Esophageal M001145570Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 08714729163169), received between Sep 13, 2018 and May 27, 2026 — classified as 4 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (76 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Incomplete or Missing Packaging

  IT WAS REPORTED THAT LABELLING ISSUE OCCURRED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS SELECTED FOR USE. DURING INSPECTION, IT WAS NOTED THAT THE BACK OF THE PACKAGING WAS LABELED "NON-STERILE." THE DEVICE WAS NOT USED, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301323 ↗
• MalfunctionMay 27, 2026Incomplete or Missing Packaging

  IT WAS REPORTED THAT LABELLING ISSUE OCCURRED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS RECEIVED IN THE HOSPITAL. UPON RECEIPT OF THE DEVICE, IT WAS NOTED THAT THE BACK OF PACKAGING SAYS "NON-STERILE". THE DEVICE WAS NOT USED IN A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300415 ↗
• MalfunctionMay 26, 2026Incomplete or Missing Packaging

  IT WAS REPORTED THAT LABELLING ISSUE OCCURRED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS RECEIVED IN THE HOSPITAL. UPON RECEIPT OF THE DEVICE, IT WAS NOTED THAT THE BACK OF PACKAGING SAYS "NON-STERILE". THE DEVICE WAS NOT USED IN A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25294385 ↗
• MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH MW5178958 THAT BALLOON DETACHMENT OCCURRED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON CATHETER DETACHED FROM THE CATHETER SHAFT DURING REMOVAL FROM THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864539 ↗
• InjuryDec 5, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING A CUT DOWN FOR REMOVAL. THE 50-60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS EXTERNAL ILIAC VEIN. AN XXL/18-4/5.8/75 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER SHAFT BROKE OFF INSIDE THE PATIENT, REQUIRING A CUT DOWN TO REMOVE THE BROKEN PIECE. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Embolism/Embolus

  MAUDE report 23733001 ↗
• InjuryOct 23, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT BALLOON CAME OFF THE SHAFT UPON REMOVAL, STUCK IN THE VEIN AND SURGICAL CUT WAS MADE TO REMOVE THE BALLOON. THE 70-90% STENOSED AND COMPRESSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED, SO FIBROUS AND SOME WEBBING PREVIOUS DEEP VEIN THROMBOSIS (DVT). AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST DILATION AFTER PLACEMENT OF AN 22X70 WALL STENT WAS PLACED ON THE LEFT SIDE. UPON REMOVAL, IT WAS NOTED THAT THE BALLOON CAME OFF THE SHAFT AND BECAME STUCK IN THE EXTERNAL ILIAC VEIN. A SURGICAL CUT DOWN TO THE LEFT COMMON FEMORAL VEIN AND INCISION MADE TO THE VEIN TO REMOVE THE BALLOON AFTER IT WAS SNARED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. PATIENT WENT HOME THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23371097 ↗
• MalfunctionOct 3, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. AN XXL/18-4/5.8/75 ESOPHAGEAL BALLOON WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN THE AORTA. DURING THE PTA PROCEDURE, THE BALLOON RUPTURED, AND THE DEVICE BECAME DIFFICULT TO REMOVE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364362 ↗
• InjuryMay 21, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS STUCK ON THE DISTAL END OF THE STENT, NECESSITATING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC VEIN, WHICH WAS MILDLY TORTUOUS, COMPRESSED, AND CALCIFIED. A 20X80X75CM VENOUS WALLSTENT WAS PLACED BY THE PHYSICIAN TO EXTEND A PREVIOUSLY PLACED STENT IN THE LEFT COMMON ILIAC VEIN. THE PHYSICIAN POST-DILATED THE LESION USING AN 18X4X75 XXL BALLOON CATHETER AND ATTEMPTED TO REPOSITION THE STENT DURING BALLOON INFLATION. HOWEVER, THE BALLOON BECAME STUCK AT THE DISTAL END OF THE WALLSTENT AND WOULD NOT RELEASE. WHEN APPLIED MORE FORCE, THE ENTIRE BALLOON DETACHED FROM THE CATHETER SHAFT. EFFORTS TO SNARE AND REMOVE THE BALLOON WERE UNSUCCESSFUL. THE BALLOON LODGED BETWEEN THE VESSEL WALL AND THE FIRST PLACED WALLSTENT IN THE LEFT COMMON ILIAC VEIN. AFTER UNSUCCESSFUL REMOVAL ATTEMPTS, THE PHYSICIAN DECIDED IT WOULD BE BEST TO LEAVE THE BALLOON CAPTURED BETWEEN THE STENT AND THE VESSEL WALL, AS IT WAS IMMOVABLE, AND THE PATIENT WAS ASYMPTOMATIC FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19361298 ↗
• MalfunctionJan 26, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSIS WAS MORE THAN 80% LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC VEIN. DURING THE PROCEDURE, A 18X90 WALLSTENT SELF-EXPANDING STENT WAS PLACED AND WAS POST-DILATED. A /18-4/5.8/75, XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATION JUST BELOW THE PROXIMAL END OF THE STENT. A KISSING TECHNIQUE WAS PERFORMED BILATERALLY. HOWEVER, DURING FIRST INFLATION, THE BALLOON WOULD NOT HOLD PRESSURE AND AT 5 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON RUPTURED. WHEN NEGATIVE PRESSURE WAS APPLIED, THERE WAS BLOOD RETURNED IN THE INDEFLATOR. THE DEVICE WAS FULLY INTACT UPON REMOVAL, AND NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER XXL BALLOON CATHETER. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592243 ↗
• MalfunctionJan 15, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. THE >50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. DURING THE PROCEDURE, AN 18X90 WALLSTENT WAS PLACED BILATERALLY ON THE INFERIOR VENA CAVA (IVC) THROUGH THE COMMON ILIAC VEIN (CIV). THEN, TWO 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE PLACED AT THE PROXIMAL OF THE STENT FOR POST-DILATION. HOWEVER, WHEN THE BALLOON CATHETERS WERE INFLATED AT 5 ATMOSPHERES FOR A FEW SECONDS, THIS BALLOON WOULD NOT HOLD PRESSURE, AND WHEN NEGATIVE PRESSURE WAS APPLIED, THERE WAS BLOOD RETURNING TO THE INDEFLATOR. CONSEQUENTLY, THE BALLOON BURST. THE BALLOON WAS REMOVED FULLY INTACT, AND 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 18512765 ↗
• MalfunctionOct 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS BEING TREATED FOR MAY THURNER. VASCULAR ACCESS WAS OBTAINED VIA THE POPLITEAL ARTERY. THE 93% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY COMPRESSED COMMON ILIAC VEIN. AFTER A 035 OPTICROSS WAS ENGAGED COAXIALLY AND A 0.035 AMPLATZ WIRE WAS CROSSED THE LESION. AN 18X90 WALLSTENT WAS PLACED IN THE LESION. THEN, AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. THE MARKER WAS IN THE PROXIMAL END OF THE STENT. HOWEVER, DURING INITIAL INFLATION AT 5 ATMOSPHERES FOR FEW SECONDS, BLOOD WAS COMING OUT TO THE INDEFLATOR ENCORE 26 UPON DEFLATION. THE BALLOON WAS REMOVED SUCCESSFULLY, AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. ANOTHER 18X4 XXL BALLOON CATHETER WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035577 ↗
• MalfunctionOct 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH MAY THURNER SYNDROME AND WAS TO UNDERGO VENOGRAM. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC VEIN. AFTER AN 18X90 WALLSTENT WAS PLACED, THE TWO 18-4/5.8/75 XXL ESOPHAGEAL BALLOONS WERE ADVANCED AND INFLATED AT 5 ATMOSPHERES (ATM) AT 5MM BELOW THE PROXIMAL END OF THE STENT. THE BALLOONS WERE DEFLATED AND MOVED DOWN FOR SECOND INFLATIONS. HOWEVER, DURING THE SECOND INFLATION AT 5 ATM FOR FEW SECONDS, ONE 18-4/5.8/75 XXL ESOPHAGEAL BALLOON FAILED TO HOLD PRESSURE AND WAS RUPTURED. WHEN THE BALLOON WAS DEFLATED, BLOOD WAS NOTICED IN INDEFLATOR. THE BALLOON WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 18X4 XXL BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995051 ↗
• MalfunctionOct 24, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20OCT2023. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE PATIENT WAS BEING TREATED FOR MAY THURNER. THE 78%TENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY COMPRESSED ILIAC VEIN. AN 18X90 WALLSTENT WAS PLACED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED AND PLACED 5MM BELOW PROXIMAL END OF THE STENT, HOWEVER, THE BALLOON WOULD NOT KEEP PRESSURE RIGHT FROM START. THE DEVICE WAS REMOVED. ANOTHER 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATION, BUT THE BALLOON WOULD NOT BE ABLE TO HOLD PRESSURE THIS TIME. THE DEVICE WAS REMOVED COMPLETELY AND REPLACED WITH A NEW 18X4 XXL BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT BALLOON HAD A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993607 ↗
• MalfunctionOct 24, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20OCT2023. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE PATIENT WAS BEING TREATED FOR MAY THURNER. THE 78%TENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY COMPRESSED ILIAC VEIN. AN 18X90 WALLSTENT WAS PLACED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED AND PLACED 5MM BELOW PROXIMAL END OF THE STENT, HOWEVER, THE BALLOON WOULD NOT KEEP PRESSURE RIGHT FROM START. THE DEVICE WAS REMOVED. ANOTHER 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATION, BUT THE BALLOON WOULD NOT BE ABLE TO HOLD PRESSURE THIS TIME. THE DEVICE WAS REMOVED COMPLETELY AND REPLACED WITH A NEW 18X4 XXL BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT BALLOON HAD A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993593 ↗
• MalfunctionSep 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH MAY THURNER SYNDROME. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED LEFT COMMON ILIAC VEIN. FOLLOWING PLACEMENT OF 18X90 WALLSTENTS BILATERALLY, TWO 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WERE BILATERALLY PLACED AT THE PROXIMAL END OF THE STENT AND INFLATED SIMULTANEOUSLY. HOWEVER, DURING THE INITIAL INFLATION AT 5 ATMOSPHERES FOR A FEW SECONDS, ONE OF THE BALLOON CATHETER RUPTURED. THE DEVICE WAS REMOVED COMPLETELY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 18X4X75 XXL ESOPHAGEAL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787160 ↗
• MalfunctionSep 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS BEING TREATED FOR MAY THURNER SYNDROME. THE 61% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED INFERIOR VENA CAVA THROUGH COMMON ILIAC VEIN. FOLLOWING IMPLANTATION OF BILATERAL 18X90 WALLSTENTS, TWO OF 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE ADVANCED FOR POST-DILATATION AT THE PROXIMAL END OF STENTS FOR KISSING BALLOON INFLATION WITH MARKERS JUST BELOW THE END OF STENTS AS PER ANGIOGRAM. THE BALLOONS WERE INFLATED SIMULTANEOUSLY; HOWEVER, ONE OF THE BALLOONS BURST DURING THE INITIAL INFLATION AT 5 ATMOSPHERES (ATM) FOR 2 SECONDS. THE BALLOON WAS REMOVED INTACT AND REPLACED WITH ANOTHER OF SAME DEVICE. MULTIPLE KISSING BALLOON INFLATIONS WERE PERFORMED FROM THE PROXIMAL TO THE DISTAL END OF STENTS AT 5 ATM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680789 ↗
• MalfunctionMay 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. AFTER THE WALLSTENT WAS PLACED, POST DILATATION WAS PERFORMED WITH A 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES FOR 10 SECONDS, THE BALLOON BURST. THE DEVICE WAS SUCCESSFULLY REMOVED WITH NO FRAGMENTS LEFT INSIDE PATIENT BODY, AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907688 ↗
• MalfunctionMay 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS BEING TREATED FOR VEIN COMPRESSION. A 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION FOR 5 ATMOSPHERES, 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 16878372 ↗
• MalfunctionMar 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS TREATED FOR MAY-THURNER SYNDROME RETURNED WITH SWELLING. VASCULAR ACCESS WAS OBTAINED VIA POPLITEAL BILATERAL APPROACH. THE TARGET LESION WAS LOCATED IN INFERIOR VENA CAVA (IVC). AFTER THE TWO 18X9 STENTS PLACED IN COMMON ILIAC VEIN EXTENDED PAST CONFLUENCE INTO IVC, THE TWO 18-4/5.8/75 XXL ESOPHAGEAL BALLOONS WERE ADVANCED FOR POST DILATATION. BOTH BALLOONS WERE PLACED AT TOP OF STENT, HOWEVER, DURING FIRST INFLATION AT 5 ATMOSPHERES (ATM), THE RIGHT SIDE BALLOON RUPTURED. ANOTHER 18X4X75 XXL ESOPHAGEAL BALLOON WAS USED AND BOTH BALLOONS WERE PLACED IN THE MIDDLE OF STENTS AND INFLATED SIMULTANEOUSLY. HOWEVER, DURING FIRST INFLATION AT 5 ATM, THE RIGHT SIDE BALLOON RUPTURED AGAIN. BOTH BALLOONS WERE REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 18X4X75 XXL ESOPHAGEAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464061 ↗
• MalfunctionMar 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS TREATED FOR MAY-THURNER SYNDROME RETURNED WITH SWELLING. VASCULAR ACCESS WAS OBTAINED VIA POPLITEAL BILATERAL APPROACH. THE TARGET LESION WAS LOCATED IN INFERIOR VENA CAVA (IVC). AFTER THE TWO 18X9 STENTS PLACED IN COMMON ILIAC VEIN EXTENDED PAST CONFLUENCE INTO IVC, THE TWO 18-4/5.8/75 XXL ESOPHAGEAL BALLOONS WERE ADVANCED FOR POST DILATATION. BOTH BALLOONS WERE PLACED AT TOP OF STENT, HOWEVER, DURING FIRST INFLATION AT 5 ATMOSPHERES (ATM), THE RIGHT SIDE BALLOON RUPTURED. ANOTHER 18X4X75 XXL ESOPHAGEAL BALLOON WAS USED AND BOTH BALLOONS WERE PLACED IN THE MIDDLE OF STENTS AND INFLATED SIMULTANEOUSLY. HOWEVER, DURING FIRST INFLATION AT 5 ATM, THE RIGHT SIDE BALLOON RUPTURED AGAIN. BOTH BALLOONS WERE REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 18X4X75 XXL ESOPHAGEAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461998 ↗
• MalfunctionDec 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL VASCULAR DISEASE (PVD) AND UNDERWENT VENOUS WALL STENTING. THE 72% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED INFERIOR VENA CAVA (IVC) TO EXTERNAL ILIAC VEIN (EIV). AFTER PLACING TWO OF 18X90 WALLSTENT, KISSING BALLOON TECHNIQUE WAS PERFORMED FOR POST-DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 5PSI, THE 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER RUPTURED AND REPLACED WITH ANOTHER BALLOON. AFTER IVUS POST PROCEDURE, ANOTHER 18X90 WALLSTENT WAS USED ON THE LEFT SIDE TO EXTEND INTO THE IVC. KISSING BALLOONS WERE USED AGAIN FOR POST-DILATATION AND ANOTHER 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER BURST DURING THE INITIAL INFLATION AT 5PSI. THE BALLOON CATHETER WAS REMOVED INTACT, 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 16054004 ↗
• MalfunctionDec 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL VASCULAR DISEASE (PVD) AND UNDERWENT VENOUS WALL STENTING. THE 72% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED INFERIOR VENA CAVA (IVC) TO EXTERNAL ILIAC VEIN (EIV). AFTER PLACING TWO OF 18X90 WALLSTENT, KISSING BALLOON TECHNIQUE WAS PERFORMED FOR POST-DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 5PSI, THE 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER RUPTURED AND REPLACED WITH ANOTHER BALLOON. AFTER IVUS POST PROCEDURE, ANOTHER 18X90 WALLSTENT WAS USED ON THE LEFT SIDE TO EXTEND INTO THE IVC. KISSING BALLOONS WERE USED AGAIN FOR POST-DILATATION AND ANOTHER 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER BURST DURING THE INITIAL INFLATION AT 5PSI. THE BALLOON CATHETER WAS REMOVED INTACT, 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 16048777 ↗
• MalfunctionAug 15, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED COMMON ILIAC VEIN. AN OPTICROSS35 IMAGING CATHETER WAS PREPPED AND INSERTED, HOWEVER, NO IMAGE APPEARED ON THE INTRAVASCULAR ULTRASOUND (IVUS) REGARDLESS OF TROUBLESHOOTING (FLUSHING AND DISCONNECTING SEVERAL TIMES). ANOTHER OPTICROSS35 IMAGING CATHETER WAS PULLED BUT HAD THE SAME ISSUE. FINALLY, AFTER POWERING OFF THE IVUS AND TRYING THE THIRD CATHETER, IT WORKED. A 18-4/5.8/75 XXL ESOPHAGEAL BALLOON DILATOR WAS ADVANCED; HOWEVER, DURING INFLATION, THE DEVICE GOT FRACTURED. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 18X4 XXL BALLOON DILATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224810 ↗
• MalfunctionMay 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 86% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC VEIN. A 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED TO POST DILATE THE TWO PLACED WALLSTENTS. HOWEVER, DURING THE FIRST INFLATION AT 3 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT'S BODY. ANOTHER 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING INITIAL INFLATION AT 3 ATMOSPHERES FOR 20 SECONDS, STILL THE BALLOON RUPTURED. THE BALLOON WAS REMOVED AND ANOTHER 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED. HOWEVER, AFTER THE BALLOON WAS INITIALLY INFLATED TO 4 ATMOSPHERES FOR 25 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH AN 18X40 XXL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14418056 ↗
• MalfunctionMay 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 86% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC VEIN. A 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED TO POST DILATE THE TWO PLACED WALLSTENTS. HOWEVER, DURING THE FIRST INFLATION AT 3 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT'S BODY. ANOTHER 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING INITIAL INFLATION AT 3 ATMOSPHERES FOR 20 SECONDS, STILL THE BALLOON RUPTURED. THE BALLOON WAS REMOVED AND ANOTHER 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED. HOWEVER, AFTER THE BALLOON WAS INITIALLY INFLATED TO 4 ATMOSPHERES FOR 25 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH AN 18X40 XXL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14416645 ↗