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 Type  malfunction  

Manufacturer Narrative

Investigation result of wire broke.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Investigation result: analysis of the returned rx cytology brush revealed that the pull wire had been kinked at different locations along the working length.Residue was present throughout the working length.Functional evaluation found the handle could be actuated through its full range of movement, but the handle felt loose and the pull wire did not move, indicating the wire had broken inside the handle t-fitting.Device was disassembled and assessment found the pull wire had been broken at the hypotube.The brush bristle section was missing, likely to have been cut off by the user to retrieve the sample.The event was most likely caused by some operational or anatomical aspect of the procedure which restricted the pull wire¿s ability to move freely within the catheter.Attempts to extend and retract the brush with pull wire movement restricted resulted in the broken pull wire.Therefore, the most probably root cause for this event is determined to be operational context.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used during a procedure.According to the complainant, during the procedure, the brush failed to retract into the sheath.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.Investigation results revealed the wire broke, therefore this event has been deemed an mdr reportable event.

• 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: 5391488
• MDR Text Key: 36851353
• Report Number: 3005099803-2016-00050
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2016

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: Physician
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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