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	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 28may2024.It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the non-tortuous and non-calcific venous artery.A 16-2/5.8/75 xxl esophageal balloon dilator was selected for treatment.The device was prepped as usual and was inserted into the body.During the procedure, the operator pulled negative on the balloon and the indiflator was filled with blood.There was no attempt to inflate the device.The device was removed and replaced with a non-boston scientific device to complete the procedure.There were no patient complications reported.However, returned device analysis revealed a balloon pinhole.
Additional Manufacturer Narrative
Device evaluated by mfr.: device returned for analysis and underwent a visual and tactile examination.The balloon was tightly folded which indicates that the balloon was not subjected to positive pressure.Blood observed inside the balloon is indicative of a device leak.A visual examination identified a balloon pinhole located approximately 2mm distal of the proximal balloon sleeve.The rated burst pressure for this device is 5 atmospheres as per specification.There were no damages or kinks noted on the shaft and 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: 19556757
• Report Number: 2124215-2024-36093
• Device Sequence Number: 6805937
• Product Code: KNQ
• UDI-Device Identifier: 08714729163039
• UDI-Public: 08714729163039
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 06/17/2024

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: 04/12/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0031414267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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 Age: 66 YR
• Patient Sex: Male