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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 02/17/2015
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used during a biopsy procedure performed on (b)(6) 2015.According to the complainant, during preparation, they found that the direction of the brush bristles was not consistent and strong resistance was met when they retracted the brush into the sheath.The procedure was completed with another rx cytology brush.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
Analysis of the returned rx cytology brush device found that the bristles on the distal third of the brush pointed toward the brush tip, and the bristles on the proximal two thirds of the brush pointed in the direction of the device handle.The bristles on this device were properly formed.Functional evaluation found that the brush would fully extend and fully retract without issue.Therefore, the most probable root cause of this complaint is ¿user preference¿ since no specification exists regarding the orientation of the brush bristles.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 during a biopsy procedure performed on (b)(6) 2015.According to the complainant, during preparation, they found that the direction of the brush bristles was not consistent and strong resistance was met when they retracted the brush into the sheath.The procedure was completed with another rx cytology brush.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
Reported event of inconsistent direction of brush bristles.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.
 
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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 Key4607040
MDR Text Key5713254
Report Number3005099803-2015-00551
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 02/17/2015
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 Physician
Device Expiration Date05/21/2016
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number16990529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2015
Initial Date FDA Received03/16/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/17/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2014
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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