MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; 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	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with claudication and underwent left leg angiogram.The 75% stenosed target lesion was located in mildly tortuous and moderately calcified left iliac vein.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilation.However, during the initial inflation, the balloon ruptured before reaching the rated burst pressure.The device was removed intact, and the procedure was completed with another xxl balloon catheter.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a xxl device 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 present in balloon which is indicative of a leak.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located 40mm proximal from the distal tip.The rated burst pressure for this device is 8 atmospheres as per xxl specification.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with claudication and underwent left leg angiogram.The 75% stenosed target lesion was mildly tortuous and moderately calcified.A 14-6/5.8/75 xxl vascular balloon dilator was advanced for dilation.However, during the procedure, the balloon ruptured seconds before reaching the rated burst pressure.The device was removed intact, and the procedure was completed with another xxl balloon.There were no patient complications and injuries reported.

• Brand Name: XXL VASCULAR
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16001559
• Report Number: 2124215-2022-52947
• Device Sequence Number: 5607140
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: 08714729190486
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150303
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: 09/13/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0030149186
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/18/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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