WALLFLEX COLONIC M00565050 6505

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 2019-02-04 for WALLFLEX COLONIC M00565050 6505 manufactured by Boston Scientific Corporation.

Event Text Entries

[134930863] (b)(6). (b)(4). According to the complainant, the suspect 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


[134930864] Note: this report pertains to one of the two devices used during the same procedure. Refer to manufacturer report # 3005099803-2019-00353 for the associated device. It was reported to boston scientific corporation on january 10, 2019 that two wallflex colonic stents were implanted to treat a 6cm stenosis in the sigmoid and descending colon during a stent placement procedure performed on (b)(6) 2018. According to the complainant, the first 12cm wallflex colonic stent (the subject of mfr. Report # 3005099803-2019-00353) was advanced through the endoscope and was deployed; however, the stent "jumped" and was placed not on the stenosis. A second 9cm wallflex colonic stent (the subject of this report) was implanted in a stent-in-stent placement. Reportedly, on (b)(6) 2018, post stent placement procedure, the patient experienced an abdominal pain. A computed tomography (ct) scan was performed and confirmed intestinal perforation. Reportedly, the perforation site was on the descending colon where the distal end of the 9cm wallflex colonic stent was in placed; however, the relationship between the stent and perforation was unknown. Antibiotic were administered to the patient. On (b)(6) 2018, the patient had expired. Per the physician, peritonitis was the cause of patient's death. Note: on january 23, 2019, boston scientific corporation received an additional information that the 9cm stent was a wallflex colonic stent.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-00380
MDR Report Key8302846
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-02-04
Date of Report2019-02-04
Date of Event2018-11-27
Date Mfgr Received2019-01-23
Device Manufacturer Date2018-08-09
Date Added to Maude2019-02-04
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 COLONIC
Generic NameSTENT, COLONIC, METALIC, EXPANDABLE
Product CodeMQR
Date Received2019-02-04
Model NumberM00565050
Catalog Number6505
Lot Number0022489507
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. Death 2019-02-04

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