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

Model Number M00545000

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

(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 wire guided was prepped for use, for a cytology procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, when the device was unpacked, it was noted that there was a foreign object in the device.The foreign object was noted to be inside the inner sterile pouch.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code 2944 captures the reportable event of foreign material present in device.Block h10: investigation results.An unused rx cytology brush was received for analysis.A visual analysis of the returned device revealed that the device was received in its original sealed pouch.A visual assessment identified a greater than 0.20 millimeter squared foreign matter in one side of the pouch no other issues were noted.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.There is an investigation to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that an rx cytology brush wireguided was prepped for use, for a cytology procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, when the device was unpacked, it was noted that there was a foreign object in the device.The foreign object was noted to be inside the inner sterile pouch.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.

• 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: 8284583
• MDR Text Key: 134323973
• Report Number: 3005099803-2019-00320
• 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: 03/25/2019

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: 10/04/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0022755762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1