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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
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date the incident occurred was estimated as (b)(6) 2019 which was two weeks later than (b)(6) 2019 when the first incident occurred.
 
Event Description
It was reported via medwatch mw5090530 that tip detachment occurred.During a procedure involving an xxl balloon catheter, tip detachment occurred.
 
Manufacturer Narrative
B3 - date the incident occurred was estimated as (b)(6) 2019 which was two weeks later than (b)(6) 2019 when the first incident occurred.
 
Event Description
It was reported via medwatch mw5090530 that tip detachment occurred.During a procedure involving an xxl balloon catheter, tip detachment occurred.It was further reported that this is the same event reported in emdr 2134265-2019-12585.
 
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Brand Name
XXL VASCULAR
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9377395
MDR Text Key173774402
Report Number2134265-2019-14486
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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