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

Model Number	23375
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Patient presented and being treated may-thurner's syndrome.The 69% stenosed target lesion was located in the mildly tortuous and severely calcified bilateral common iliac artery and right external iliac artery.Two 16-4/5.8/75 xxl esophageal balloon catheter were advanced for kissing balloon inflation.However, first 16-4/5.8/75 xxl balloon catheter would not inflate right off from the start.The device was removed and replaced with another 16-4/5.8/75 xxl balloon catheter, but during the first inflation at 5 atmospheres, the balloon burst with blood noted returned in the indeflator.The device was also removed, and another of the same balloon catheter was used and the procedure completed.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.Patient presented and being treated may-thurner's syndrome.The 69% stenosed target lesion was located in the mildly tortuous and severely calcified bilateral common iliac artery and right external iliac artery.Two 16-4/5.8/75 xxl esophageal balloon catheter were advanced for kissing balloon inflation.However, first 16-4/5.8/75 xxl balloon catheter would not inflate right off from the start.The device was removed and replaced with another 16-4/5.8/75 xxl balloon catheter, but during the first inflation at 5 atmospheres, the balloon burst with blood noted returned in the indeflator.The device was also removed, and another of the same balloon catheter was used and the procedure completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the xxl/16-4/5.8/75 was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood observed inside the balloon is indicative of a device leak.A balloon longitudinal tear was identified beginning approximately 27mm proximal of the distal tip and extending approximately 7mm proximally across the balloon material.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination identified no issues with the tip of the device.This concludes the product analysis.

• 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: 17562772
• Report Number: 2124215-2023-43729
• Device Sequence Number: 17841856
• Product Code: KNQ
• UDI-Device Identifier: 08714729163060
• UDI-Public: 08714729163060
• 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): 09/13/2023

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 Expiration Date: 02/01/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0030977625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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: Unknown