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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH
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BOSTON SCIENTIFIC - SPENCER RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH Back to Search Results
Model Number M00545000
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used during a cytology procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the device was extended and retracted, the brush became bent and was unable to be used.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no injury¿ at the conclusion of the procedure.
 
Manufacturer Narrative
A rx cytology brush was received for analysis.A visual evaluation of the returned device revealed that it was received in retracted position.Further evaluation noted that the working length (pull wire and extrusion) was kinked in several locations including the bristled portion of the brush.No other anomalies were noted.The reported event that the brush section was bent was confirmed.It is most likely that the working length may have been damaged (kinked) due to the interaction with the scope or excessive manipulation of the device by the user.The investigation concluded that the observed failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.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.A search of the complaint database revealed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used during a cytology procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the device was extended and retracted, the brush became bent and was unable to be used.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no injury¿ at the conclusion of the procedure.
 
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Brand Name
RX CYTOLOGY BRUSH
Type of Device
ENDOSCOPIC CYTOLOGY BRUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7441278
MDR Text Key106013395
Report Number3005099803-2018-01176
Device Sequence Number1
Product Code FDX
UDI-Device Identifier08714729268628
UDI-Public08714729268628
Combination Product (y/n)N
PMA/PMN Number
K930348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/15/2019
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number21518166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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