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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
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/28/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: pediatric case, below 18 years old.
 
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in the moderately tortuous and non-calcified pulmonary artery.A 14-2/5.8/75 xxl balloon catheter was used for dilatation.However, difficulties were encountered during removal and the balloon could not be removed.Subsequently, the sheath and balloon were removed together.The procedure was completed and there were no patient complications nor injuries reported.
 
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Brand Name
XXL VASCULAR
Common Device Name
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10438756
Report Number2134265-2020-10474
Device Sequence Number2816470
Product Code LIT
UDI-Device Identifier08714729162926
UDI-Public08714729162926
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K150303
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/21/2020
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 Date11/17/2022
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0024784143
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/29/2020
Initial Report FDA Received Date08/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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