CELLEBRITY? M00516071 1607

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 2018-07-24 for CELLEBRITY? M00516071 1607 manufactured by Boston Scientific - Spencer.

Event Text Entries

[114847735] The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. (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


[114847736] It was reported to boston scientific corporation that a celebrity cytology brush was opened for use during a cytology procedure performed on (b)(6) 2018. According to the complainant, during preparation, when the device was checked, it was noticed that the wire inside the catheter broke and the brush failed to extend and retract. The procedure was completed with another celebrity cytology brush. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be good.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2018-02406
MDR Report Key7713866
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-07-24
Date of Report2018-07-05
Date of Event2018-07-05
Date Mfgr Received2018-07-05
Date Added to Maude2018-07-24
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 ContactEMP. NANCY CUTINO
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Manufacturer G1BOSTON SCIENTIFIC - SPENCER
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 NameCELLEBRITY?
Generic NameBRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
Product CodeBTG
Date Received2018-07-24
Model NumberM00516071
Catalog Number1607
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - SPENCER
Manufacturer Address780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-24

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