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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 06/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(b)(4).The device has been received for analysis; however 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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was prepared for use in the bile duct to diagnose a suspected bile duct cancer during a scraping cytology procedure performed on (b)(6) 2019.According to the complainant, during preparation and outside the patient, when trying to retract the brush, the exposed wire near the bristled portion was found to be bent.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block e1: initial reporter address: (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.Functional evaluation of the returned device revealed that the handle operation was smooth and the brush would retract and extend normally.However, upon visual inspection, it was revealed that a bent/kink was found in the brush section of the device.No other issues were noted.Based on the event description the problem was noticed during preparation.Handling and manipulation of the device during unpacking/prepping can lead to bend the device.Bends in the device are typically caused by handling of the device, also the way in which the device was unpacked could have bent the device.Based on the information available and the analysis performed, the most probable root cause classification 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.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was prepared for use in the bile duct to diagnose a suspected bile duct cancer during a scraping cytology procedure performed on (b)(6) 2019.According to the complainant, during preparation and outside the patient, when trying to retract the brush, the exposed wire near the bristled portion was found to be bent.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.
 
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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 Key8798435
MDR Text Key151304799
Report Number3005099803-2019-03451
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 08/13/2019
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 Date02/07/2021
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number0023316315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Initial Date Manufacturer Received 06/25/2019
Initial Date FDA Received07/17/2019
Supplement Dates Manufacturer Received07/26/2019
Supplement Dates FDA Received08/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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