CRE FIXED WIRE M00558370 5837

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 2020-03-26 for CRE FIXED WIRE M00558370 5837 manufactured by Boston Scientific Corporation.

Event Text Entries

[185196957] Date of event was approximated to (b)(6) 2019 as no event date was reported. (b)(4). Visual examination of the returned complaint device found the balloon did not show visual defects and looked normal. No damage found on the catheter of the device. Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the distal section on the body of the balloon. 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 lesion characteristics, the manner in which the device was handled and manipulated and the technique used by the physician during the procedure. 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.
Patient Sequence No: 1, Text Type: N, H10


[185196958] It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a procedure performed on an unknown date. According to the complainant, during the preparation, it was noted that there was a hole in the white connector part in the base of the delivery. The procedure was completed with another cre fixed wire dilatation balloon. No patient complications have been reported as a result of the event. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts. Investigation results revealed that the balloon had a pinhole; therefore, this is now an mdr reportable event
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2020-01197
MDR Report Key9883062
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2019-12-01
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-06-27
Date Added to Maude2020-03-26
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 Street00 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 NameCRE FIXED WIRE
Generic NameDILATOR, ESOPHAGEAL
Product CodeKNQ
Date Received2020-03-26
Returned To Mfg2020-01-29
Model NumberM00558370
Catalog Number5837
Lot Number0024021674
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 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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