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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
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the external iliac vein.A 16-4/5.8/75 xxl esophageal balloon catheter was advanced for post-dilatation.However, upon inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
 
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Brand Name
XXL ESOPHAGEAL
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9514570
MDR Text Key177125171
Report Number2134265-2019-16109
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729163060
UDI-Public08714729163060
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/25/2022
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0024014197
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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