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

Model Number	23375
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and detachment occurred.The patient presented with venous compression.The 80% stenosed target lesion was located in the non-tortuous and non-calcified right iliac vein.A 14-4/5.8/75 xxl vascular balloon catheter was advanced to reopen a previously placed wallstent.However, during the initial inflation at 8 atmospheres, the balloon ruptured horizontally.A portion of the balloon was left in the patient and a snare had to be used to retrieve the remaining piece.The procedure was completed with a 12x4 athletis balloon catheter.There were no patient complications reported and the patient was fully recovered.
Event or Problem Description
It was reported that balloon rupture and detachment occurred.The patient presented with venous compression.The 80% stenosed target lesion was located in the non-tortuous and non-calcified right iliac vein.A 14-4/5.8/75 xxl vascular balloon catheter was advanced to reopen a previously placed wallstent.However, during the initial inflation at 8 atmospheres, the balloon ruptured horizontally.A portion of the balloon was left in the patient and a snare had to be used to retrieve the remaining piece.The procedure was completed with a 12x4 athletis balloon catheter.There were no patient complications reported and the patient was fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis.A visual examination identified a complete circumferential tear of the balloon material located approximately 40mm distal of the proximal sleeve of the balloon.The distal section of balloon material had been completely detached from the device due to a shaft break.The distal section of the balloon material including the tip of the device and a section of shaft were not returned for analysis.This type of damage is consistent with excessive tensile force being applied to the device.The rate of burst pressure of this device is 8atm.A visual and tactile examination found the shaft to have been detached at two locations.The first break was located approximately 27mm distal of the proximal balloon sleeve and the second approximately 70mm distal of the first break.The distal section of the shaft including a section of balloon material and the tip were not returned for analysis.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination of the markerbands identified that one markerband was detached from the device and the second had become loose on the shaft.This type of damage most probably occurred due to the severe shaft damage.The detached markerband was not returned for analysis.A visual examination of the device identified a section of shaft including a section of balloon material and the tip were not returned for analysis.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16009676
• Report Number: 2124215-2022-52253
• Device Sequence Number: 12210846
• Product Code: LIT
• UDI-Device Identifier: 08714729190462
• UDI-Public: 08714729190462
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/02/2023

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: 04/21/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0029267165
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown