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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 Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/01/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.Used the first date of the month of the aware date.
 
Event Description
It was reported that shaft break occurred.After a wallstent was implanted in the lesion, an xxl vascular balloon catheter was advanced for post dilation; however, part of the balloon broke off and was floating around the patient's heart during the procedure.Two snaring attempts were made after it migrated post detachment but they were unable to retrieve the detached component.No further patient complications were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8176995
MDR Text Key130777052
Report Number2134265-2018-64233
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952656
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 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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