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

Model Number	23375
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The patient underwent a venogram to be treated for may thurners on the bilateral common iliac vein.The target lesion was a compression of 80% stenosis, mildly tortuous and a compression of severe calcification.Bilateral 18-90 wallstents were placed, and post dilatation was done with two 6/5.8/75 xxl balloon catheters.Both balloons inflated at 5 atmospheres until it was noted that one of the balloons would not hold pressure.Upon removing, a small hole was identified.The device was replaced for another of the same model to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: xxl device was returned for analysis.A visual examination was performed on the balloon which was not folded which indicates that the balloon was subjected to positive pressure.The balloon was attached to an encore inflator.It was subjected to positive pressure and deionised water was observed to be leaking from the balloon where a balloon was found located 14mm proximal from the distal markerband.The rated burst pressure for this device is 8 atmospheres as per xxl specification.The shaft and tip underwent a visual and tactile examination where a shaft kink approximately 1mm distal from the distal end of the hub was found.No issues with the tip of the device.
Event or Problem Description
It was reported that balloon pinhole occurred.The patient underwent a venogram to be treated for may thurners on the bilateral common iliac vein.The target lesion was a compression of 80% stenosis, mildly tortuous and a compression of severe calcification.Bilateral 18-90 wallstents were placed, and post dilatation was done with two 6/5.8/75 xxl balloon catheters.Both balloons inflated at 5 atmospheres until it was noted that one of the balloons would not hold pressure.Upon removing, a small hole was identified.The device was replaced for another of the same model to complete the procedure.No patient complications were reported.

• 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: 18906172
• Report Number: 2124215-2024-15077
• Device Sequence Number: 20793305
• Product Code: KNQ
• UDI-Device Identifier: 08714729163114
• UDI-Public: 08714729163114
• 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): 04/09/2024

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: 05/11/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0031605128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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