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

Model Number	23375
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occured.The target lesion was located in a iliac venous compression syndrome.A 16-2/5.8/120 xxl was selected.However, during unpacking, the shaft broke.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a visual and microscopic examination was performed on the returned xxl device.The device was returned with the balloon protector in position over the balloon material.The balloon was tightly folded and had not been subjected to positive pressure.No damage or any issues were noted with the balloon material that could have contributed with the complaint incident.A visual and tactile examination identified no damage or any issues along the length of the device that could have contributed to the complaint incident.No device separation or fracturing were identified.No damage or any issues were noted with the tip or markerbands that could have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occured.The target lesion was located in a iliac venous compression syndrome.A 16-2/5.8/120 xxl was selected.However, during unpacking, the shaft broke.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8274225
• Report Number: 2134265-2019-00309
• Device Sequence Number: 13779737
• Product Code: KNQ
• UDI-Device Identifier: 08714729163053
• UDI-Public: 08714729163053
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 08/26/2021
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0022567096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 70