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,foreig report with the FDA on 2019-05-07 for OCCLUDER M0062201090 220-109 manufactured by Boston Scientific Corporation.

Event Text Entries

[144272278] (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[144272279] This report pertains to one of two occlusion balloon catheters used in the same patient and procedure. It was reported to boston scientific corporation that two occlusion balloon catheters were used in the ureter during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the balloon burst. The same issue occurred with the second occlusion balloon catheter. The procedure was completed with another occlusion balloon catheter. There were no patient complications reported as a result of this event. The patient condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-02391
MDR Report Key8586323
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-07
Date of Report2019-08-13
Date of Event2019-04-11
Date Mfgr Received2019-07-23
Device Manufacturer Date2019-01-11
Date Added to Maude2019-05-07
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 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 Received2019-05-07
Model NumberM0062201090
Catalog Number220-109
Lot Number0023173580
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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
10 2019-05-07

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