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	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occured.The 65% stenosed target lesion was located in the mild to moderately tortuous left common iliac vein.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilation.However, during the fourth inflation at 4 atmospheres for 10 seconds or less, the balloon ruptured.The device was successfully removed from the patient and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a xxl/14-6/5.8/75 balloon catheter was received for analysis.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 visual examination identified a balloon pinhole located approximately 22mm distal of the proximal markerband.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.
Event or Problem Description
It was reported that balloon rupture occured.The 65% stenosed target lesion was located in the mild to moderately tortuous left common iliac vein.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilation.However, during the fourth inflation at 4 atmospheres for 10 seconds or less, the balloon ruptured.The device was successfully removed from the patient and the procedure was completed with another of the same device.There were no patient complications nor 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12907484
• Report Number: 2134265-2021-15068
• Device Sequence Number: 17145192
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: 08714729190486
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 09/30/2024
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0028124444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Patient Race: White