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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 Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event was estimated as (b)(6) 2019 based on the initial event aware date of (b)(6)2019. An xxl /14-6/5. 8/75 was returned for analysis. A visual examination identified that the balloon wings were in a relaxed state and had been subjected to positive pressure. A visual and microscopic examination found the balloon material to have 2 small longitudinal tears at the location of the distal marker band. The first, measuring approximately 10mm and the second measuring 5 mm. An examination of the balloon material and the distal markerband identified no issues which could potentially have contributed to this complaint. A visual and microscopic examination of the marker bands identified no issues which may potentially have contributed to the complaint incident. The marker bands were not found to be raised, cracked or damaged in any way. A visual and tactile examination found no issues with the shaft of the device. A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident. No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 7 oct 2020. It was reported that a balloon leak occurred. The patient presented for left iliac venous trunk angioplasty due to post-thrombotic syndrome. When an xxl/14-6/5. 8/75 vascular balloon was removed from the package and tested, a leak was noted. The device could not be used and the procedure was completed with another. However, device analysis revealed two small longitudinal tears in the balloon material.
 
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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 Key10744681
MDR Text Key213420417
Report Number2134265-2020-14904
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K150303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 10/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2021
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0022535812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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