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

Model Number	23375
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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 it popped from the tip when post-ballooning.There were no complications reported, and patient status was stable.
Event or Problem Description
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 it popped from the tip when post-ballooning.There were no complications reported, and patient status was stable.It was further reported that the target area is a compression one with no lesion.The balloon had ruptured after the first inflation.It was quick, up and down, and estimated to be under 30 seconds.

• 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: 18991236
• Report Number: 2124215-2024-18556
• Device Sequence Number: 19605311
• Product Code: KNQ
• UDI-Device Identifier: 08714729163190
• UDI-Public: 08714729163190
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0032767685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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
• Patient Sex: Female