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

Model Number M00545000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Device component code relates to device problem code 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

It was reported to boston scientific corporation that an rx cytology brush was prepared for use during a procedure.According to the complainant, during preparation, it was noted that there was less bristles on the brush and the bristled portion of the device was bent.The procedure was completed with another rx cytology brush.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

The lot number received with the returned device.Investigation results: an rx cytology brush was returned for analysis.A visual evaluation of the returned device revealed that it was received in a retracted position, and it also revealed that the working length (extrusion and pull wire) was free from obvious kinks and bends.No visual issues were identified with the bristled section of the device.A functional analysis was performed and showed that the device was able to extend and retract without any issues.Brush extension and retraction dimension were measured to be within specifications.The brush outer diameter and length were also measured to be within specifications.The complaint was not confirmed.The returned device showed no evidence of the alleged issues, or any defect which could have contributed to the event.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 prepared for use during a procedure.According to the complainant, during preparation, it was noted that there was less bristles on the brush and the bristled portion of the device was bent.The procedure was completed with another rx cytology brush.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.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7297052
• MDR Text Key: 101150177
• Report Number: 3005099803-2018-00418
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

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: 11/03/2019
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0021336519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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