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

Model Number	23375
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leakage on the balloon occurred.A 16-4/5.8/75 xxl balloon dilator was selected for treatment for may thurner.Above 80 compression was noted in the common iliac vein and an 18x90 wallstent device was placed.When the balloon was inserted, there was negative pressure pulled with the indeflator and blood was coming back to it.The device was removed and replaced with another of the same model to complete the procedure.No complications were reported, and the patient was in a stable condition.
Event or Problem Description
It was reported that leakage on the balloon occurred.A 16-4/5.8/75 xxl balloon dilator was selected for treatment for may thurner.Above 80 compression was noted in the common iliac vein and an 18x90 wallstent device was placed.When the balloon was inserted, there was negative pressure pulled with the indeflator and blood was coming back to it.The device was removed and replaced with another of the same model to complete the procedure.No complications were reported, and the patient was in a stable condition.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis completed.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was observed inside the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 4mm distal of the proximal balloon bond.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination identified no issues with the tip of the device.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18466324
• Report Number: 2124215-2023-75281
• Device Sequence Number: 3087885
• Product Code: KNQ
• UDI-Device Identifier: 08714729163060
• UDI-Public: 08714729163060
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/13/2024

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: 04/10/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0031396893
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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: Unknown