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 06/25/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was opened for use in the common bile duct during a biopsy procedure performed on (b)(6) 2014.According to the complainant, during unpacking, it was noted that the bristles in the proximal to middle portion of the brush were bent down toward the handle.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

(b)(4) for the reported event of brush bristles bent.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Manufacturer Narrative

Investigation results: visual evaluation of the returned device found the brush was fully extended and did not show any bends or kinks.However, magnification of the returned device showed dark materials on the distal portion of the brush and the bristles on the distal portion of the brush were facing toward the handle.The complaint that the brush bent was confirmed.The brush was placed under magnification and found fibers and dark materials at the distal part of the brush.Also, the distal portion of the brush was noticed to be pointing towards the handle.There is no specification regarding orientation of the brush bristles and the bristles on this device appear to be properly formed.Therefore, the most probable root cause for this event is determined to be "user preference issue".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.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was opened for use in the common bile duct during a biopsy procedure performed on (b)(6) 2014.According to the complainant, during unpacking, it was noted that the bristles in the proximal to middle portion of the brush were bent down toward the handle.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: 3949708
• MDR Text Key: 20264909
• Report Number: 3005099803-2014-02566
• 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,Followup
• Report Date: 06/30/2014

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 Expiration Date: 03/05/2016
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16795960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 07/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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