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

Model Number M00545000

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018 as no event date was reported.Investigation results: an rx cytology brush was returned for analysis.A visual analysis of the returned device revealed that residues were found inside the extrusion, which indicated use and handling of the device.The working length (extrusion and pull wire) was kinked in several locations.The handle was kinked and separated from the device.The pull wire was kinked and broken adjacent to the handle cannula joint.The brush section and the extrusion were cut at distal end.Marks in the cut ends of the wire and extrusion indicated that an unknown tool was used to cut the device.It is most likely that the failures found (pull wire/extrusion kinked/broken, handle kinked/separated) were caused due to excessive manipulation as the customer brushed back and forth during procedure.Handling and manipulation of the device can lead to kinking of the extrusion and pull wire.This condition can cause difficulties to extend the brush, and excessive force applied to the handle in order to extend the brush can result in bending of the handle and kinking of the pull wire at handle cannula joint.Also continued movements of the handle to extend the brush can result in pull wire breakage and consequently the handle separation from the device.Based on the information available and the analysis performed, the most probable root cause for this event is "adverse event related to procedure." 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.

Event Description

It was reported to boston scientific corporation that an rx cytology brush wireguided was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, when extending and retracting the brush, the handle/wire broke off the brush.The procedure was completed with another rx cytology brush.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.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the pull wire was detached/separated.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8370791
• MDR Text Key: 137173073
• Report Number: 3005099803-2019-00806
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2019

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: Health Professional
• Device Expiration Date: 06/29/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0022321667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1