MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL

Model Number	23375
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulty and shaft break occurred.The target lesion was located in the non-tortuous and non-calcified common iliac vein.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilatation and was inflated once in a previously implanted area.Upon removal of the device, it became stuck and was caught on the stent struts.The device then broke off.The entire portion of the balloon was completely removed from the opposite groin through a large sheath.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a xxl device was returned for analysis.A visual examination identified a complete circumferential tear was identified located approximately 35mm proximal of the distal tip.A section of the balloon was detached.The remainder section of the balloon was attached to the shaft.A visual examination identified that the shaft was detached 18mm distal from the distal end of the hub.A visual and tactile examination identified multiple shaft kinks and was also accordioned.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 removal difficulty and shaft break occurred.The target lesion was located in the non-tortuous and non-calcified common iliac vein.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilatation and was inflated once in a previously implanted area.Upon removal of the device, it became stuck and was caught on the stent struts.The device then broke off.The entire portion of the balloon was completely removed from the opposite groin through a large sheath.The procedure was completed with a different device.No patient complications were 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: 13341788
• Report Number: 2134265-2022-00249
• Device Sequence Number: 3958182
• 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): 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2024
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0028357702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown