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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 12/09/2013
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2013.According to the complainant, the indication of the procedure was to search for a tumor in the biliary duct.It was reported that resistance was felt when the brush was passing through the working channel.The brush was then remove from the endoscope and was noted to be completely bent in the bristled portion.The procedure was completed by another rx cytology brush.There were no patient complications reported as a result of this event.At the conclusion of the procedure, it was reported that the ¿patient was and is well.¿.
 
Manufacturer Narrative
Reported event: brush bent.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
Investigation results: visual evaluation of the returned device found the brush bent, and kinks were found in the working length.Functional evaluation found that the brush extended with ease; however, it would not fully retract due to the bent brush.The device was inserted in a scope with a working channel of 2.8mm.Resistance was encountered once the kinked areas of the device were introduced, and much effort was required to fully pass the device through the scope.The complaint was confirmed.It is likely that the brush bent during insertion into the endoscope, which subsequently affected its ability to retract.Therefore, the most probable root cause of this failure 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 revealed that no other complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2013.According to the complainant, the indication of the procedure was to search for a tumor in the biliary duct.It was reported that resistance was felt when the brush was passing through the working channel.The brush was then remove from the endoscope and was noted to be completely bent in the bristled portion.The procedure was completed by another rx cytology brush.There were no patient complications reported as a result of this event.At the conclusion of the procedure, it was reported that the ¿patient was and is well.¿.
 
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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 Key3547838
MDR Text Key4102683
Report Number3005099803-2013-14858
Device Sequence Number1
Product Code FDX
Combination Product (y/n)N
Reporter Country CodeCH
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 12/09/2013
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 Date03/15/2015
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number15952976
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2013
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2014
Initial Date FDA Received01/02/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/13/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age69 YR
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