MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number M00545000

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a biliary rx cytology brush wireguided was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the bristled portion of the brush tip was kinked.The procedure was completed with another biliary cytology brush.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a biliary rx cytology brush wireguided was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the bristled portion of the brush tip was kinked.The procedure was completed with another biliary cytology brush.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Problem code 2981 captures the reportable event of brush bent.Investigation results: visual evaluation of the returned device revealed that no visual defects were noted, the returned device looked under good conditions without evidence of damages.The brush (bristled portion) was not kinked/bent.Functional evaluation was performed and revealed that when the handle was actuated, the brush was able to extend and retract without any issues.Based on the information available and the analysis performed, the most probable root cause is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8132875
• MDR Text Key: 129344578
• Report Number: 3005099803-2018-61743
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• 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
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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: 08/19/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0022536709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1