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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 06/08/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous right iliac vein.A 14-2/5.8/75 xxl vascular balloon was advanced for dilatation.However, during initial inflation, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications nor injuries reported.
 
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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 Key10140393
Report Number2134265-2020-07838
Device Sequence Number19358214
Product Code LIT
UDI-Device Identifier08714729162926
UDI-Public08714729162926
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K150303
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/10/2020
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 Date07/15/2022
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0024116314
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/08/2020
Initial Report FDA Received Date06/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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