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

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Visual evaluation of the returned rx cytology brush found that the working length which includes catheter and the pull wire had been kinked in multiple locations.The thumb ring hypotube was bent.In addition, the working length had been cut at the distal end and the pull wire was found broken.The brush bristle section was not present and was not returned for analysis.Functional evaluation could not be performed due to working length was cut and pull wire broken.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.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database confirmed that no other complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the bile passage during a cytology procedure.According to the complainant, during the procedure, severe resistance was encountered when extending and retracting the brush into the catheter which make it difficult to obtain tissue.The procedure was completed with this device.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.This event has been deemed a reportable event based on the investigation results; wire broke.

• 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: 6171038
• MDR Text Key: 62381524
• Report Number: 3005099803-2016-03820
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: (01)08714729268628(17)20180630(10)19422769
• 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: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 19422769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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