OCCLUDER M0062201090 220-109

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 2019-04-04 for OCCLUDER M0062201090 220-109 manufactured by Boston Scientific Corporation.

Event Text Entries

[140921266] (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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[140921267] It was reported to boston scientific corporation that an occluder ballon catheter was used in a procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the balloon burst.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-01610
MDR Report Key8483233
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-04
Date of Report2019-06-04
Date of Event2019-02-15
Date Mfgr Received2019-05-20
Device Manufacturer Date2018-12-05
Date Added to Maude2019-04-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 CORK LIMITED
Manufacturer StreetCORK BUSINESS TECHNOLOGY PARK MODEL FARM ROAD
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOCCLUDER
Generic NameCATHETER, UROLOGICAL
Product CodeEYB
Date Received2019-04-04
Returned To Mfg2019-04-15
Model NumberM0062201090
Catalog Number220-109
Lot Number0023035830
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-04

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