WALLFLEX DUODENAL M00565020 6502

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 2019-03-12 for WALLFLEX DUODENAL M00565020 6502 manufactured by Boston Scientific Corporation.

Event Text Entries

[138580197] The complainant was unable to provide the suspect device lot number. Therefore, the manufacture and expiration dates are unknown. (b)(4). The complainant indicated that the suspect device remains implanted 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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[138580198] It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex duodenal stent has been implanted to treat a malignant stricture in the duodenum during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2017. Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement. During the initial placement, the stent was slightly adjusted with rat tooth forceps. According to the complainant, on (b)(6) 2019, the patient presented with pain. The physician performed direct visualization to check for stent placement, and noticed that the wires at the end of the stent were exposed and were not joined/ connected. Reportedly, the stent remains implanted and the physician was comfortable leaving the stent in place. It is unknown if the patient received any treatment for pain. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-01117
MDR Report Key8413985
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-12
Date of Report2019-03-12
Date of Event2019-02-15
Date Mfgr Received2019-02-15
Date Added to Maude2019-03-12
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 ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1BOSTON SCIENTIFIC IRELAND LIMITED
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALLFLEX DUODENAL
Generic NameSTENT,METALLIC,EXPANDABLE,DUODENAL
Product CodeMUM
Date Received2019-03-12
Model NumberM00565020
Catalog Number6502
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 2019-03-12

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