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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2018
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 filed.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was prepared to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during preparation, when the brush was advanced out of the catheter, the device was difficult to retract.It was also reported that the wire inside the sheath was broken.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Investigation results: a visual evaluation of the returned rx cytology brush revealed that the pull wire was broken at the distal end of the handle cannula, and it was also noticed that a kink was found in the same location.Further evaluation noted that the extrusion is free of obvious kinks and bends.A functional analysis was not performed due to the condition of the returned device.It is most likely that the pull wire being kinked at the distal end of the handle cannula could have caused difficulty to retract the brush.Due to excessive manipulation of the device, it would cause the pull wire to break.Based on all gathered information, the most probable cause of this complaint is ¿manufacturing process design¿, since it is most likely due to design or validation of the manufacturing process not being sufficient to ensure that the finished device met the intent of the design.There is an investigation in place to address this issue.A review of the device history record (dhr) was performed and no deviations were found.
 
Event Description
It was reported to boston scientific corporation that an rx cytology brush was prepared to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during preparation, when the brush was advanced out of the catheter, the device was difficult to retract.It was also reported that the wire inside the sheath was broken.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
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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
MDR Report Key7301051
MDR Text Key101165040
Report Number3005099803-2018-00494
Device Sequence Number1
Product Code FDX
UDI-Device Identifier08714729268628
UDI-Public08714729268628
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
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/17/2019
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number21401967
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2018
Date Manufacturer Received03/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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