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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 Date 01/21/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during an exfoliative cytodiagnosis procedure performed on (b)(6) 2014.According to the complainant, during the procedure, after the brush was inserted in the endoscope and into the bile duct, an attempt was made by the physician to push the brush out of the catheter.Resistance was met and brush would not come out.The physician applied force and the brush came out bent.The first brush was exchanged for another rx cytology brush which completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
 
Manufacturer Narrative
(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.
 
Manufacturer Narrative
Visual evaluation of the returned device shows the brush and the working length was bent in several locations.Functional test was done and the brush was able to extend without issue but would not fully retract due to the bent brush.The device was inserted into the endoscope and resistance was met due to the bent areas in the working length.The device started kinking and could not pass through the endoscope.The complaint that the brush was bent was confirmed.Most probably, insertion of the device into the endoscope could have cause the brush and the working length to bend.The brush could not fully retract into the catheter due to the bent brush.Therefore, the most probable root cause of the failure identified is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no other complaints exist for the specified batch. .
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during an exfoliative cytodiagnosis procedure performed on (b)(6) 2014.According to the complainant, during the procedure, after the brush was inserted in the endoscope and into the bile duct, an attempt was made by the physician to push the brush out of the catheter.Resistance was met and brush would not come out.The physician applied force and the brush came out bent.The first brush was exchanged for another rx cytology brush which completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
 
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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
ingrid matte
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key3620134
MDR Text Key18855705
Report Number3005099803-2014-00866
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 Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/01/2015
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number16280735
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2013
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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