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 05/01/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was opened for use on (b)(6) 2014.According to the complainant, during preparation, the brush could not be retracted into the sheath.It was reported that the bristles of the brush were pointing in a different direction than usual, leading the customer to believe that the device had been improperly assembled.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

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 was performed and found no anomalies.The bristles were straight.Functional test were performed, device actuated and it can extend and retract without difficulties.The complaint that the bristles were bent and difficult to retract was not confirmed.Based on all tests performed, the device was within specification and found neither the alleged issue or defect which could have contributed to the event.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 on (b)(6) 2014.According to the complainant, during preparation, the brush could not be retracted into the sheath.It was reported that the bristles of the brush were pointing in a different direction than usual, leading the customer to believe that the device had been improperly assembled.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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3836316
• MDR Text Key: 4408321
• Report Number: 3005099803-2014-02124
• 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: 05/02/2014

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: Health Professional
• Device Expiration Date: 10/29/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16493210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 05/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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