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	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty.A 14-4/5.8/75 xxl vascular balloon catheter was advanced for dilation.However, during inflation within the nominal rated pressure, the balloon burst.The procedure was completed with another of the same device.No patient complications were reported, and the patient condition was good.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty.A 14-4/5.8/75 xxl vascular balloon catheter was advanced for dilation.However, during inflation within the nominal rated pressure, the balloon burst.The procedure was completed with another of the same device.No patient complications were reported, and the patient condition was good.It was further reported that the 70% stenosed target lesion was located in the mildly tortuous and moderately calcified central vein.The balloon ruptured during inflation at 12 atmospheres for 30 seconds.
Additional Manufacturer Narrative
Device evaluated by mfr.: a xxl device was returned for analysis, the following attributes were considered during analysis: a visual examination identified that a partial circumferential tear 7mm proximal from the distal tip.From the partial circumferential tear, the balloon was also torn longitudinal for approximately 25mm in a proximal direction.A visual and tactile examination identified a shaft kink 10mm distal from the distal end of the hub.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty.A 14-4/5.8/75 xxl vascular balloon catheter was advanced for dilation.However, during inflation within the nominal rated pressure, the balloon burst.The procedure was completed with another of the same device.No patient complications were reported, and the patient condition was good.It was further reported that the 70% stenosed target lesion was located in the mildly tortuous and moderately calcified central vein.The balloon ruptured during inflation at 12 atmospheres for 30 seconds.

• Brand Name: XXL VASCULAR
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16765390
• Report Number: 2124215-2023-18192
• Device Sequence Number: 6182034
• Product Code: LIT
• UDI-Device Identifier: 08714729190462
• UDI-Public: 08714729190462
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2023

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: 09/15/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0030161241
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 05/25/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/03/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• 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: Female