ULTRAFLEX ESOPHAGEAL NG M00513750 1375

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 2020-02-24 for ULTRAFLEX ESOPHAGEAL NG M00513750 1375 manufactured by Boston Scientific Corporation.

Event Text Entries

[188653820] (b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[188653821] It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex esophageal ng distal release covered stent was to be used to treat an 8-9cm stricture in the esophagus due to cancer during an esophageal metal stenting procedure performed on (b)(6) 2020. Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement. According to the complainant, during the procedure, the stent failed to expand after complete deployment of the stent deployment suture. The stent remained at its position on the delivery system and was removed with forceps. The procedure was completed with a different device. 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 Number3005099803-2020-00454
MDR Report Key9747205
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-24
Date of Report2020-02-24
Date of Event2020-01-30
Date Mfgr Received2020-01-30
Device Manufacturer Date2019-05-01
Date Added to Maude2020-02-24
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 Received2020-02-24
Model NumberM00513750
Catalog Number1375
Lot Number0023724393
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 2020-02-24

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