MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; DILATOR, ESOPHAGEAL

Model Number	23375
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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 stent struts, the left 18x6 xxl balloon burst.The right 18x6 xxl esophageal balloon was removed without difficulty.The xxl balloon on the left was fully deflated but was difficult to remove.It was noted that it most likely got caught on the end of the sheath.Force was used to remove the balloon, and when removed, it dislodged from the catheter and could not be seen on fluoroscopy.The sheath was removed, and the physician attempted a cut down to locate the balloon but was unsuccessful.It was noted that the balloon was lodged in the popliteal vein.The patient was taken to the hospital for surgery to remove the dislodged balloon.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the patient outcome procedure, but further information was unable to be obtained.
Additional Manufacturer Narrative
The b1 adverse event/product problem was inadvertently left blank in the previous submission.The mustang device was returned for analysis, and the investigation was completed on april 3, 2025.Upon visual examination, it was noted that the balloon was not folded, suggesting that it had been subjected to positive pressure.A complete circumferential tear was identified in the balloon, located approximately 15mm distal to the proximal balloon bond.However, the distal section of the balloon material was not returned for analysis.The rated burst pressure for this device is 5 atmospheres.Further visual and tactile examination revealed that the shaft of the device was separated at a point approximately 90mm distal to the proximal marker band.The distal portion of the shaft, including the distal marker band, tip, and balloon material, was not returned for analysis.Additionally, the shaft was found to be kinked and severely stretched, beginning at the proximal balloon bond and extending to the proximal marker band.Visual and tactile inspection confirmed that the proximal marker band remained in place on the shaft of the device.However, the distal section of the shaft, including the tip, was not returned for further analysis.
Event or Problem Description
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 stent struts, the left 18x6 xxl balloon burst.The right 18x6 xxl esophageal balloon was removed without difficulty.The xxl balloon on the left was fully deflated but was difficult to remove.It was noted that it most likely got caught on the end of the sheath.Force was used to remove the balloon, and when removed, it dislodged from the catheter and could not be seen on fluoroscopy.The sheath was removed, and the physician attempted a cut down to locate the balloon but was unsuccessful.It was noted that the balloon was lodged in the popliteal vein.The patient was taken to the hospital for surgery to remove the dislodged balloon.It was further reported that there was no resistance encountered until attempting to remove the balloon through the sheath.The inflation medium used was a mixture of 70% saline and 30% contrast.The patient tolerated the procedure well and did well post-surgery.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21712804
• Report Number: 2124215-2025-18011
• Device Sequence Number: 18660032
• Product Code: KNQ
• UDI-Device Identifier: 08714729163190
• UDI-Public: (01)08714729163190(17)261115(10)32866678
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0032866678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Patient Race: Black Or African American