RX CYTOLOGY BRUSH M00545000 4500

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 2019-04-23 for RX CYTOLOGY BRUSH M00545000 4500 manufactured by Boston Scientific Corporation.

Event Text Entries

[142779070] Date of event was approximated to be (b)(6) 2019 as no event date was reported. (b)(6). (b)(4). An rx cytology brush was returned for analysis. A visual analysis of the returned device revealed that the working length (extrusion and pull wire) was kinked in several locations. The handle was separated from the device. The pull wire was kinked and broken adjacent to the handle cannula joint. In addition, the distal section of the pull wire was extended and it was observed that the brush section was cut at distal end, marks in the cut ends of the wire indicated that an unknown tool was used to cut the device. Functional inspection was performed and the pull wire failed to retract. It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity. Likely the failures found (pull wire/extrusion kinked/broken, handle separated) were caused due to manipulation as the customer brushed back and forth during procedure. Handling and manipulation of the device can lead to kinking of the extrusion and pull wire. This condition can cause difficulties to extend/retract the brush. Force applied to the handle in order to extend/retract the brush can result in kinking the pull wire at handle cannula joint, also continued movements of the handle to extend/retract the brush can result in pull wire breakage and consequently the handle separation from the device. Based on the information available and the analysis performed, 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 at the time of release for distribution.
Patient Sequence No: 1, Text Type: N, H10


[142779071] It was reported to boston scientific corporation that an rx cytology brush wireguided was used in the bile duct during a cytology procedure performed on an unknown date. According to the complainant, during the procedure, after scraping was performed and when the brush was retracted into the catheter, the brush was unable to retract. The procedure was completed with another rx cytology brush. There were no patient complications reported as a result of this event. Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the wire was broken.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-02115
MDR Report Key8540441
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-04-23
Date of Report2019-04-23
Date of Event2019-03-01
Date Mfgr Received2019-04-02
Device Manufacturer Date2018-09-28
Date Added to Maude2019-04-23
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 NameRX CYTOLOGY BRUSH
Generic NameENDOSCOPIC CYTOLOGY BRUSH
Product CodeFDX
Date Received2019-04-23
Returned To Mfg2019-03-18
Model NumberM00545000
Catalog Number4500
Lot Number0022698146
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 2019-04-23

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