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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL Back to Search Results
Model Number 23375
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Used (b)(6) 2018 as event date as there was no event date reported.
 
Event or Problem Description
It was reported that balloon rupture occurred.A 14-4/5.8/120mm xxl vascular balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another xxl balloon catheter.No patient complications were reported and the patient was not harmed.
 
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Brand Name
XXL VASCULAR
Common Device Name
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7902523
Report Number2134265-2018-61245
Device Sequence Number169153
Product Code LIT
UDI-Device Identifier08714729190479
UDI-Public08714729190479
Combination Product (Y/N)N
Initial Reporter StateWY
Initial Reporter CountryUS
PMA/510(K) Number
K150303
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/24/2018
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 Date03/06/2021
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0021830952
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2018
Initial Report FDA Received Date09/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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