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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 Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2016
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).Analysis of the returned rx cytology brush found that the catheter and pull wire were kinked at multiple locations throughout; the catheter was not detached or separated.The handle was disassembled and there were residues found which indicate use and handling.The pull wire was found broken at the distal end.The bristled portion of the brush was not present and was not returned for evaluation.The drag marks at the distal end of the pull wire were caused by the customer when they attempted to cut the pull wire.Functional analysis was not performed due to pull wire was broken.A labeling review was performed and from the information available, this device was used in a manner inconsistent with the labeled indications.The dfu states ¿precaution: before using, inspect the package for any breach to confirm the product¿s sterility.If the package has been opened, do not use the catheter.1.Remove the rx cytology brush wireguided cytology brush from its package and inspect for any damage.¿ in this case, this device was used even after the was damage noted during preparation.Therefore, the most probable root cause classification is user/use error.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was opened for use during a scraping cytology procedure performed on (b)(6) 2016.According to the complainant, during preparation, the physician noticed that the blue tip of the catheter tip was detached.Although the damage was noted during preparation, the physician chose to use this device to complete the procedure.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no problem¿ at the conclusion of the procedure.
 
Manufacturer Narrative
Investigation results: analysis of the returned rx cytology brush found that the catheter and pull wire were kinked at multiple locations throughout; the catheter was not detached or separated.The handle was disassembled and there were residues found which indicate use and handling.The pull wire was found broken at the distal end.The bristled portion of the brush was not present and was not returned for evaluation.The drag marks at the distal end of the pull wire were caused by the customer when they attempted to cut the pull wire.Functional analysis was not performed due to pull wire was broken.A labeling review was performed and from the information available, this device was used in a manner inconsistent with the labeled indications.The dfu states ¿precaution: before using, inspect the package for any breach to confirm the product¿s sterility.If the package has been opened, do not use the catheter.Remove the rx cytology brush wireguided cytology brush from its package and inspect for any damage.¿ the kinks in the catheter and pull wire were most likely due to operational/physiological context issues encountered during the procedure.Therefore, the root cause for this event is most likely determined to be operational context.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was opened for use during a scraping cytology procedure performed on (b)(6) 2016.According to the complainant, during preparation, the physician noticed that the blue tip of the catheter tip was detached.Although the damage was noted during preparation, the physician chose to use this device to complete the procedure.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no problem¿ 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
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6168973
MDR Text Key62190979
Report Number3005099803-2016-03678
Device Sequence Number1
Product Code FDX
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberM00545000
Device Catalogue Number4500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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