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  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used for a procedure.According to the complainant, the brush could not be retracted into the catheter.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.Investigation results revealed the brush was bent, therefore this event has been deemed an mdr reportable event.

Manufacturer Narrative

(b)(4).Analysis of the returned rx cytology brush device confirmed the reported complaint.The brush was in a partially retracted position, with the pull wire bent in the middle of the bristled portion and the bent part of the brush/wire outside the catheter.Functional evaluation found that the brush could be extended without resistance and could not be fully retracted into the catheter due to the bent pull wire.Additionally, residue was present on the entire device and the working length was bent at multiple locations throughout.Therefore, the most probable root cause is operational context, since residue on the bristles indicates that the device was used in the procedure and the issue was likely due to procedural/anatomical factors.

• 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: 4674243
• MDR Text Key: 20722497
• Report Number: 3005099803-2015-00908
• Device Sequence Number: 1
• Product Code: FDX
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2015

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: 09/23/2016
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 17307454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• 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