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	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the balloon was damaged by the stent.A xxl vascular balloon and wallstent were selected for use.The wallstent was successfully implanted and the xxl vascular balloon was chosen for post-dilation.As the balloon crossed the implanted stent, it became damaged by the stent.The balloon was unable to inflate, and blood was returning in the balloon catheter.Another xxl balloon was used for post-dilation.There were no patient complications.
Event or Problem Description
It was reported the balloon was damaged by the stent.A xxl vascular balloon and wallstent were selected for use.The wallstent was successfully implanted and the xxl vascular balloon was chosen for post-dilation.As the balloon crossed the implanted stent, it became damaged by the stent.The balloon was unable to inflate, and blood was returning in the balloon catheter.Another xxl balloon was used for post-dilation.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned and analysis was completed.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A balloon pinhole located approximately 5mm proximal of the tip of the device.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no damage or kinks on the shaft of the device.A visual and microscopic examination of the tip and markerbands identified no damage or any issues that could have contributed to the complaint incident.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13282679
• Report Number: 2134265-2022-00091
• Device Sequence Number: 20042466
• Product Code: LIT
• UDI-Device Identifier: 08714729190479
• UDI-Public: 08714729190479
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 10/11/2024
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0028188048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown