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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(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 bile duct during a procedure.According to the complainant, during the procedure, when the brush was manipulated, the device was difficult to extend and retract.It was also reported that the wire inside the catheter broke.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
An rx cytology brush was returned for analysis.A visual evaluation of the returned rx cytology brush revealed that the pull wire was broken at the distal end of the handle cannula, and there was evidence that the pull wire was kinked in the same location.The working length (pull wire and extrusion) was bent in several locations.Further evaluation noted that the bristled portion of the brush was cleanly cut off likely with a sharp tool.A functional analysis was not performed due to the condition of the returned device.The complaint was confirmed.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Likely the bends in the working length of the pull wire and extrusion were caused by handling and manipulation of the device.Therefore, the most probable root cause of these failures is operational context.It is likely that the kink in the pull wire at the distal end of the handle cannula could have caused difficulty extending/retracting.Continued attempts to extend/retract the brush could have then resulted in the pull wire breaking at the kink.Based on all gathered information, the most probable root cause of the kink and break in the pullwire at the distal end of the handle cannula is ¿manufacturing process design¿, since it is most likely that design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.There is an investigation in place to address this issue.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.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during a procedure.According to the complainant, during the procedure, when the brush was manipulated, the device was difficult to extend and retract.It was also reported that the wire inside the catheter broke.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Investigation results: a visual evaluation of the returned rx cytology brush revealed that the pull wire was broken at the distal end of handle cannula, and it was also noticed that a kink was found in the same location.The working length (pull wire and extrusion) was bent in several locations.Further evaluation noted that the bristled portion of the brush was cut by the customer with a sharp tool.A functional analysis was not performed due to the condition of the returned device.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Likely the failures found, working length (pull wire and extrusion) bent were caused due to excessive manipulation by customer during the procedure.Handling and manipulation of the device can lead to the catheter and pull wire being kinked and it would cause the pull wire to break.This condition can caused difficulty to extend/retract the brush due to excessive force being applied to the handle.During manufacturing, the devices were inspected for functionality and integrity, however, there is no control on how the product is handled at the field.Based on all gathered information, the most probable cause of this complaint is ¿manufacturing process design¿, since it is most likely that design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.There is an investigation in place to address this issue.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 bile duct during a procedure.According to the complainant, during the procedure, when the brush was manipulated, the device was difficult to extend and retract.It was also reported that the wire inside the catheter broke.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
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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 Key7297327
MDR Text Key101121597
Report Number3005099803-2018-00492
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,Followup
Report Date 02/06/2018
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 Date12/07/2019
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number21482135
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2018
Initial Date Manufacturer Received 02/06/2018
Initial Date FDA Received02/26/2018
Supplement Dates Manufacturer Received03/08/2018
04/02/2018
Supplement Dates FDA Received03/15/2018
04/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
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