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 Date 07/30/2014

Event Type  malfunction  

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 a cytology procedure performed on (b)(6) 2014.According to the complainant, during preparation, an attempt to retract the brush back into the sheath failed.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.

Manufacturer Narrative

Investigation result of brush bent.Investigation results: analysis of the returned rx cytology brush device confirmed that the brush was difficult to retract.The working length was coiled and twisted.Additionally, the proximal end of the brush was bent.The brush extends with no difficulties.Therefore, the most probable root cause for this failure is handling damage since the issue was noted during the preparation and outside the patient.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 other complaints exist for the specified batch.

• 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: 4153015
• MDR Text Key: 4911468
• Report Number: 3005099803-2014-03268
• 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: 09/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/29/2016
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16698874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2014
• 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