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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 Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 in the common bile duct during a cytology procedure.According to the complainant, during the procedure, when the brush was attempted to extend out of the catheter, the device was difficult to advance.The operator removed the device with force and it was noted that the bristled portion of the brush was bent.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 visual evaluation of the returned rx cytology brush revealed that the device was received in partially retracted position.Further evaluation noted that the working length (pull wire and extrusion) kinked/bent in several locations and the bristled portion of the brush was kinked.A functional analysis was performed and revealed that the brush was not able to extend and retract properly due to the damages found on the device.It is most likely that during the procedure the device could have been excessively manipulated so the device was unable to extend/retract due to the damages found.The kinks found could have affected the device¿s extension and retraction ability.This failure directly impacts the performance of the product during use.Based on all gathered information, the most probable cause of this complaint is ¿operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure the performance of the device was limited.A review of the device history record (dhr) was performed and no deviations were found.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a cytology procedure.According to the complainant, during the procedure, when the brush was attempted to extend out of the catheter, the device was difficult to advance.The operator removed the device with force and it was noted that the bristled portion of the brush was bent.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
MDR Report Key7293439
MDR Text Key101009241
Report Number3005099803-2018-00419
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 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/18/2019
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number21273467
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2018
Date Manufacturer Received02/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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