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	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 86% stenosed target lesion was located in the mildly tortuous and severely calcified left common iliac vein.A 18-4/5.8/75 xxl esophageal balloon catheter was advanced to post dilate the two placed wallstents.However, during the first inflation at 3 atmospheres for 30 seconds, the balloon ruptured.The device was removed completely from the patient's body.Another 18-4/5.8/75 xxl esophageal balloon catheter was advanced.However, during initial inflation at 3 atmospheres for 20 seconds, still the balloon ruptured.The balloon was removed and another 18-4/5.8/75 xxl esophageal balloon catheter was advanced.However, after the balloon was initially inflated to 4 atmospheres for 25 seconds, the balloon ruptured.The device was completely removed from the patient's body.The procedure was completed with an 18x40 xxl balloon catheter.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 86% stenosed target lesion was located in the mildly tortuous and severely calcified left common iliac vein.A 18-4/5.8/75 xxl esophageal balloon catheter was advanced to post dilate the two placed wallstents.However, during the first inflation at 3 atmospheres for 30 seconds, the balloon ruptured.The device was removed completely from the patient's body.Another 18-4/5.8/75 xxl esophageal balloon catheter was advanced.However, during initial inflation at 3 atmospheres for 20 seconds, still the balloon ruptured.The balloon was removed and another 18-4/5.8/75 xxl esophageal balloon catheter was advanced.However, after the balloon was initially inflated to 4 atmospheres for 25 seconds, the balloon ruptured.The device was completely removed from the patient's body.The procedure was completed with an 18x40 xxl balloon catheter.There were no patient complications reported.It was further reported that physician was aware that 3 xxl esophageal balloon catheters were used off label in a venous setting to post dilate a placed stents.Due to the size of the iliac vein, xxl was the only balloon available.

• Brand Name: XXL ESOPHAGEAL
• 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: 14416645
• Report Number: 2134265-2022-05604
• Device Sequence Number: 17524702
• Product Code: KNQ
• UDI-Device Identifier: 08714729163169
• UDI-Public: 08714729163169
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/26/2022

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: 08/14/2022
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0024270053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Race: Black Or African American