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 06/26/2014

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 procedure performed on (b)(6) 2014.According to the complainant, during preparation, the brush and the working length of the device were found to be bent.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 fine.

Manufacturer Narrative

Reported event: brush bent.The complaint device has been received by the manufacturer; however, a failure analysis has not yet been completed.Upon receipt of the failure analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Investigation results: visual evaluation found that the handle cannula was bent and the working length was twisted.Functional test was performed, and resistance felt when brush was actuated.The complaint that the brush bent was not confirmed.Brush was difficult to actuate due to the bent handle cannula.However, the complaint that the working length bent was confirmed.The brush and the drive wire at the distal part did not have any issues.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 procedure performed on (b)(6) 2014.According to the complainant, during preparation, the brush and the working length of the device were found to be bent.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 fine.

• 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: 3944765
• MDR Text Key: 18026715
• Report Number: 3005099803-2014-02519
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2014

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: 08/01/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16280733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2014
• Initial Date FDA Received: 07/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2013
• 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