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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; 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 04/13/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the non-tortuous and non-calcified right iliac vein.A 16-4/5.8/120 xxl esophageal balloon catheter was advanced for dilatation.However, on initial inflation at 5 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed with another of the same balloon.There were no patient complications reported.
 
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Brand Name
XXL ESOPHAGEAL
Common Device Name
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10025505
Report Number2134265-2020-05193
Device Sequence Number2937900
Product Code KNQ
UDI-Device Identifier08714729163084
UDI-Public08714729163084
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/05/2020
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 Date06/25/2022
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0024014199
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/13/2020
Initial Report FDA Received Date05/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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