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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 02/07/2018
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4) for the reported event of brush bent.The device has not been received for analysis.Upon receipt and 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
Note: this report pertains to the first of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-00470 for the other associated device information.It was reported to boston scientific corporation that two rx cytology brushes were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the bristled portion of the brush was bent and the device failed to advance through the scope.It was also reported that the brush was unable to retract inside the catheter.The procedure was completed with a different device.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 fine.
 
Manufacturer Narrative
An rx cytology brush was received for analysis.A visual evaluation of the returned device revealed that it was received in retracted position.Further evaluation noted that the working length (catheter and wire) was kinked in several locations.It was also noticed that the distal tip of the brush was kinked at a 90 degree angle.A functional analysis was performed and revealed that the brush could be extended but with resistance due to the damages found on the device, also it could not be retracted since the tip was kinked at an angle of 90 degrees, which impeded the brush from being able to go back inside the catheter.The catheter outer diameter was inspected at three points, distal, middle and proximal.All three points were found to be within manufacturing specifications.The reported event that the brush section was bent was confirmed.It is most likely that the working length and brush tip may have been kinked due to the interaction with the scope or excessive manipulation of the device by the user.The investigation concluded that the observed failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.
 
Event Description
Note: this report pertains to the first of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-00470 for the other associated device information.It was reported to boston scientific corporation that two rx cytology brushes were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the bristled portion of the brush was bent and the device failed to advance through the scope.It was also reported that the brush was unable to retract inside the catheter.The procedure was completed with a different device.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 fine.
 
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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 Key7301259
MDR Text Key101174298
Report Number3005099803-2018-00469
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,health
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 Model NumberM00545000
Device Catalogue Number4500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Date Manufacturer Received05/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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