WALLFLEX BILIARY M00570370 7037

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 2020-02-20 for WALLFLEX BILIARY M00570370 7037 manufactured by Boston Scientific Corporation.

Event Text Entries

[188652016] (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


[188652017] It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex biliary rx fully covered rmv stent was to be used to treat a less than 2 cm benign stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020. Reportedly, patient's anatomy was not dilated prior to stent placement. According to the complainant, during the procedure, the stent was able to be deployed. However, under endoscopic visualization, it was noticed that the stent failed to expand. The physician removed the stent with forceps and a 10 x 40 wallflex biliary stent was placed to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition following the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2020-00450
MDR Report Key9734627
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-20
Date of Report2020-02-20
Date of Event2020-01-27
Date Mfgr Received2020-01-29
Device Manufacturer Date2019-06-28
Date Added to Maude2020-02-20
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 NameWALLFLEX BILIARY
Generic NameBILIARY STENT SYSTEM FOR BENIGN STRICTURES
Product CodePNB
Date Received2020-02-20
Model NumberM00570370
Catalog Number7037
Lot Number0024029422
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 2020-02-20

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