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

Model Number M00545000

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the wire was broken.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient "condiion" following the procedure was reported to be stable.

Manufacturer Narrative

Block e1: the initial reporter address is:(b)(6).Block h6: problem code 1069 captures the reportable event of wire broken.Block h10: investigation results an rx cytology brush was received for analysis.Visual inspection of the returned device revealed that the pull wire was broken and removed from its original position.No other issues were noted.Based on the event description, the problem was noticed during procedure and inside the patient.It is possible that operational factors such as user technique/handling during procedure contributed to the observed pull wire broken.This condition could have been generated by manipulation and/or any force applied by the user to the device.Based on the information available and the analysis performed, the most probable root cause classification is adverse event related to procedure.A risk review of the biliary cytology was completed using (b)(6), risk analysis workbook- biopsy brushes, bsc, av and confirmed that the event of wire break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the wire was broken.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient condiion following the procedure was reported to be stable.

• 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: 9457735
• MDR Text Key: 189771585
• Report Number: 3005099803-2019-05947
• 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: 02/25/2020

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: 09/15/2021
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0024436790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1