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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CELLEBRITY; BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
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BOSTON SCIENTIFIC CORPORATION CELLEBRITY; BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) Back to Search Results
Model Number M00516151
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
Note: this report pertains to one of ten devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, and 3005099803-2020-02815 for the associated device information.It was reported to boston scientific corporation that at least ten cellebrity cytology brushes were opened and used during an unknown procedure performed on an unknown date.According to the complainant, during the procedure, the yellow sheathing that housed the brush was coming off where it meets the handle.When the catheter slid distally down towards the bristled portion of the brush, it prevented the brush from extending and working properly.Reportedly, it covered the brush when the handle was fully open.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 fine.
 
Event Description
Note: this report pertains to one of ten devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 and 3005099803-2020-02815 for the associated device information.It was reported to boston scientific corporation that at least ten cellebrity cytology brushes were opened and used during an unknown procedure performed on an unknown date.According to the complainant, during the procedure, the yellow sheathing that housed the brush was coming off where it meets the handle.When the catheter slid distally down towards the bristled portion of the brush, it prevented the brush from extending and working properly.Reportedly, it covered the brush when the handle was fully open.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 fine.Update based on review september 01, 2020.Note: based on further review of the event, "yellow sheathing that housed the brush was coming off where it meets the handle", it was determined that the medical device report (mdr) was sent in error.The yellow sheathing detached at the device handle, outside the patient.The detachment of the sheath at this location could not fully fall in the patient requiring intervention for retrieval.This event did not, and could not, lead to a serious injury.There is no opportunity for the failure to cause a patient injury if it were to recur.This event does not meet medical device reporting criteria and is not considered a reportable event.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code 2907 captures the reportable event of working length detached/separated.Block h10: the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: block b5 has been updated based on record review on 01sep2020.
 
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Brand Name
CELLEBRITY
Type of Device
BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10295178
MDR Text Key199761601
Report Number3005099803-2020-02814
Device Sequence Number1
Product Code BTG
UDI-Device Identifier08714729014003
UDI-Public08714729014003
Combination Product (y/n)N
PMA/PMN Number
K780872
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/19/2022
Device Model NumberM00516151
Device Catalogue Number1615
Device Lot Number0025378329
Was Device Available for Evaluation? No
Date Manufacturer Received09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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