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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter name and address: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 bile duct smear cytology procedure performed on (b)(6) 2021.During the procedure, during an attempt to retract the brush, the wire became separated.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used during a bile duct smear cytology procedure performed on (b)(6) 2021.During the procedure, during an attempt to retract the brush, the wire became separated.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 city).(b)(6).Block h6: problem code a0401 captures the reportable event of wire break.Blocl h10: (product investigation).One rx cytology brush was received for analysis.Visual inspection of the returned device revealed that the working length was kinked, approximately at 65cm from the black heat shrink.In addition, the device was disassembled and it was observed that the pull wire was broken adjacent to the handle cannula joint.No other issues were noted.The reported complaint was confirmed.The working length was found kinked/bent, which could be due to the amount of force applied and manipulation during the procedure.It was possible that the way in which the device was handled and manipulated may have contributed to the encountered failure (wire break).As per complaint information the issue occurred during the procedure.It was most likely that procedural factors, such as user technique/handling or excess force applied during its use could have affected the device performance and its integrity.In addition, handling and manipulation of the device during the procedure can lead to the broken pull wire from the handle cannula.Therefore, the most probable root cause for this problem is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.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.
 
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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 Key12304160
MDR Text Key265982419
Report Number3005099803-2021-03941
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 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/08/2023
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number0027104944
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2021
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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