XXL ESOPHAGEAL 23375

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for XXL ESOPHAGEAL 23375 manufactured by Boston Scientific Corporation.

Event Text Entries

[183329766] It was reported that balloon rupture occurred. The 98% stenosed target lesion was located in the non-calcified left common femoral vein. An 18-6/5. 8/75 xxl esophageal balloon catheter was advanced for dilatation. However, during inflation at 3 atmospheres for 5 minutes, the balloon ruptured. The balloon was removed over the wire and completed the procedure with another of the same device. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-02699
MDR Report Key9826218
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-02-20
Date Mfgr Received2020-02-20
Device Manufacturer Date2019-07-31
Date Added to Maude2020-03-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXXL ESOPHAGEAL
Generic NameDILATOR, ESOPHAGEAL
Product CodeKNQ
Date Received2020-03-12
Model Number23375
Catalog Number23375
Lot Number0024192688
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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