MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number M00545000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the brush was advanced over the guidewire through the target site.The site was brushed several times, and after completion the brush was removed from the scope.When trying to obtain the tissue sample, it was noticed that the bristled portion of the brush was detached, and inside the scope.The detached portion of the brush was retrieved successfully from the scope with string and the procedure was completed with this 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 stable.

Manufacturer Narrative

Investigation results: an rx cytology brush was returned for analysis.A visual evaluation of the returned device revealed that the pull wire was kinked and broken at its proximal section (distal end of the handle cannula) and separated (pulled out) from the inside of the extrusion.Further evaluation noted that the distal section of the pull wire (where the bristled portion of the brush is placed) was cleanly cut off, likely with a sharp tool; the brush bristle section was not present and was not returned for evaluation.A functional analysis was not performed due to the condition of the returned device.No other issues were noted.The reported event that the bristled portion of the brush was detached could not be confirmed; however, the investigation did confirm the reported event that the distal section of the pull wire was cleanly cut off, likely with a sharp tool.It is most likely that the pull wire may have been damaged (kinked and broken) due to excessive manipulation by the user or interaction with scope and with other devices.The failures found (pull wire kinked and broken) are consistent with ones caused when excess of force is applied to the product during its use or while the handle was being actuated if this function was performed not in a straight way (bending the device).Under those conditions, the pull wire can easily be pulled out from the extrusion since it is not properly attached.On the other hand, the distal section of the pull wire (where the bristled portion of the brush is placed) was cleanly cut off, without irregularities, which showed that the detachment was not caused due to excessive force applied by the user.The device was cut in order to collect the sample taken.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.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.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 used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the brush was advanced over the guidewire through the target site.The site was brushed several times, and after completion the brush was removed from the scope.When trying to obtain the tissue sample, it was noticed that the bristled portion of the brush was detached, and inside the scope.The detached portion of the brush was retrieved successfully from the scope with string and the procedure was completed with this 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 stable.

• 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 Key: 7422967
• MDR Text Key: 105398768
• Report Number: 3005099803-2018-01046
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2019
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 21542840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1