UROMAX ULTRA KIT M0062251210 225-121

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 2019-04-30 for UROMAX ULTRA KIT M0062251210 225-121 manufactured by Boston Scientific Corporation.

Event Text Entries

[143681351] (b)(4). Investigation results: visual examination of the returned complaint device revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure. Functional analysis was performed, and the balloon was inflated; however, the balloon would not hold pressure due to a pinhole located at the centre of the distal markerband. This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the manner in which the device was handled, the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the balloon, and/or the interaction between the scope and the balloon. Therefore, the most probable root cause is adverse event related to procedure. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications. A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label.
Patient Sequence No: 1, Text Type: N, H10


[143681352] It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, it was noticed that the balloon had a hole when tried to be inflated. The procedure was completed with another uromax ultra dilatation balloon catheter device. There were no patient complications reported as a result of this event. Investigation results revealed that the balloon found a pinhole; therefore, this is now an mdr reportable event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-02241
MDR Report Key8566328
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-30
Date of Report2019-04-30
Date of Event2019-03-13
Date Mfgr Received2019-04-18
Device Manufacturer Date2019-03-07
Date Added to Maude2019-04-30
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 IRELAND LIMITED
Manufacturer StreetBALLYBRIT BUSINESS PARK ,
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUROMAX ULTRA KIT
Generic NameDILATOR, CATHETER, URETERAL
Product CodeKOE
Date Received2019-04-30
Returned To Mfg2019-04-01
Model NumberM0062251210
Catalog Number225-121
Lot Number0023448968
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 017521242 US 017521242


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-30

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