ULTRAFLEX ESOPHAGEAL NG M00514240 1424

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-28 for ULTRAFLEX ESOPHAGEAL NG M00514240 1424 manufactured by Boston Scientific Corporation.

Event Text Entries

[188208386] (b)(6). (b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[188208387] It was reported to boston scientific corporation on january 05, 2020 that an ultraflex esophageal ng proximal release covered stent was to be used to treat a 5-cm malignant stricture in the mid-part of the esophagus during endoscopy procedure on (b)(6) 2020. Reportedly, the patient's anatomy was not tortuous but was considerably tight and was not dilated prior to stent placement. According to the complainant, during the procedure, the stent was able to be deployed; however, the stent failed to expand to its expected diameter as it did not touch the esophagus wall. The stent was removed with a biopsy forceps. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2020-00144
MDR Report Key9639735
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-28
Date of Report2020-01-28
Date of Event2020-01-04
Date Mfgr Received2020-01-05
Device Manufacturer Date2019-05-27
Date Added to Maude2020-01-28
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 ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
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 NameULTRAFLEX ESOPHAGEAL NG
Generic NamePROSTHESIS, ESOPHAGEAL
Product CodeESW
Date Received2020-01-28
Model NumberM00514240
Catalog Number1424
Lot Number0023855327
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.