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

Model Number M00545000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4) for the evaluation result of wire broke.Investigation results analysis of the returned rx cytology brush did not confirm the reported complaint.The brush, working length, and the t-fitting was taken off and not returned.The distal end of the handle cannula was found to be broken.Additionally, the wire was found to be bent.Therefore, the most probable root cause is operational context since the device was difficult to use and was forcefully used and made the wire bend and break.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

Event Description

Note: this event, as reported, did not reflect an mdr reportable scenario; however, evaluation of the returned device revealed an mdr-reportable malfunction.This manufacturer report is being submitted based on the evaluation results.It was reported to boston scientific corporation that an rx cytology brush was used in the pancreatic duct during a cytology procedure performed on (b)(6) 2014.According to the complainant, during the procedure, when the device was actuated, the handle cannula 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 good.

• 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: 4174118
• MDR Text Key: 21221025
• Report Number: 3005099803-2014-03329
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/01/2016
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16941743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2014
• 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