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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH
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BOSTON SCIENTIFIC CORPORATION RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH Back to Search Results
Model Number M00545000
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2019
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(6).(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
It was reported to boston scientific corporation that an rx cytology brush was used during a cytology procedure performed on an unknown date.According to the complainant, during preparation, when the device was unpacked, the bristled portion of the brush got bent.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used during a cytology procedure performed on an unknown date.According to the complainant, during preparation, when the device was unpacked, the bristled portion of the brush got bent.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
Block b3: date of event the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block e1: the initial reporter's address is (b)(6).Block h6: problem code 2981 captures the reportable event of brush bent.Block h10: investigation results an rx cytology brush was received for analysis.Visual evaluation of the returned device revealed that no kinks or abnormalities were found along the device, the device appears to be in good conditions.Functional evaluation revealed that the brush was able to extend and retract without any issue and the handle operation was smooth.In addition, the dimensional inspection of the brush fully extended, brush fully retracted, and catheter length was performed and the measurements were found within manufacturing specification.Based on the information available and the analysis performed, the most probable root cause of the reported event is no problem detected, since the reported problem cannot be confirmed.
 
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Brand Name
RX CYTOLOGY BRUSH
Type of Device
ENDOSCOPIC CYTOLOGY BRUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8821709
MDR Text Key152060952
Report Number3005099803-2019-03530
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
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/27/2020
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number0022313183
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Initial Date Manufacturer Received 07/05/2019
Initial Date FDA Received07/24/2019
Supplement Dates Manufacturer Received08/14/2019
Supplement Dates FDA Received09/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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