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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
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  Injury  
Event Description
It was reported that balloon detachment occurred. A 14-4/5. 8/75 xxl vascular balloon catheter was advanced for dilatation. However, when the device was removed, it was noted that some of it sheared off inside the patient. Subsequently, the physician then flossed the wire left to right and pushed balloon out with a guide catheter. The sheared off piece was successfully retrieved from the groin sheath. No patient complications were reported.
 
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Brand NameXXL VASCULAR
Type of DeviceDILATOR, 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 Key14160363
MDR Text Key289673323
Report Number2134265-2022-03868
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0028740325
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/20/2022 Patient Sequence Number: 1
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