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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 12/05/2016
Event Type  malfunction  
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 file.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was opened for use during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2016.According to the complainant, during preparation, the brush failed to retract inside the catheter and when about to check the device, the bristled portion of the brush was attached in the opposite direction.The brush was unable to fit inside the plastic sheath.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 complication¿ at the conclusion of the procedure.
 
Manufacturer Narrative
Investigation results: analysis of the returned rx cytology brush found no issue with the bristled portion of the brush.The device was in opened or extended position when it was received.The brush bristled section was present, properly formed, and without issue.There were no kinks noted when the device was fully extended.Functional evaluation showed that the handle operated smoothly and the brush could be fully extended and retracted without issue.There is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the most probable root cause classification is "not confirmed." a review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was opened for use during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2016.According to the complainant, during preparation, the brush failed to retract inside the catheter and when about to check the device, the bristled portion of the brush was attached in the opposite direction.The brush was unable to fit inside the plastic sheath.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 complication¿ 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 Key6200559
MDR Text Key63200405
Report Number3005099803-2016-04056
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 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date07/31/2018
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number19512662
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2016
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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