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

Model Number	23375
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the aorta.A 14-4/5.8/120mm xxl balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of different device.No patient complications were reported and the patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: a xxl/14-4/5.8/120 was returned for analysis.A visual examination identified the returned balloon folds were relaxed.Blood was in the balloon which is indicative of a leak.The device was attached to an encore inflation device and positive pressure was applied.A pinhole leak was identified 10mm proximal of distal markerband.An examination of the balloon material and markerband identified no further issues.A visual and tactile examination identified no issues with the tip of the device that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the aorta.A 14-4/5.8/120mm xxl balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of different device.No patient complications were reported and the patient's status was good.

• Brand Name: XXL VASCULAR
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9728551
• Report Number: 2134265-2020-01739
• Device Sequence Number: 2179849
• Product Code: LIT
• UDI-Device Identifier: 08714729190479
• UDI-Public: 08714729190479
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K150303
• 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): 04/15/2020

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: 04/22/2022
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0023682696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR