ADVANIX PANCREATIC STENT M00537330 3733

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 2020-03-30 for ADVANIX PANCREATIC STENT M00537330 3733 manufactured by Boston Scientific Corporation.

Event Text Entries

[185595312] (b)(6). (b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[185595313] It was reported to boston scientific corporation that an advanix pancreatic stent was used in a procedure in the pancreatic duct, performed on (b)(6), 2020. According to the complaint, during the pancreatic duct stent placement procedure, the pigtail of the stent was kinked. Reportedly, there was no health damage to the patient. The procedure was completed successfully with another advanix pancreatic stent. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2020-01365
MDR Report Key9897508
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-07-29
Date Added to Maude2020-03-30
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 Street780 BROOKSIDE DRIVE
Manufacturer CitySPENCER IN 47460
Manufacturer CountryUS
Manufacturer Postal Code47460
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVANIX PANCREATIC STENT
Generic NameCATHETER, BILIARY, DIAGNOSTIC
Product CodeFGE
Date Received2020-03-30
Returned To Mfg2020-03-24
Model NumberM00537330
Catalog Number3733
Lot Number0024183820
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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