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

Model Number M00545000

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2019 as no event date was reported.(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 wireguided was used during an unknown procedure on an unknown date.According to the complainant, it was noted that the end was broken, it snapped and could not be used.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that an rx cytology brush wireguided was used during an unknown procedure on an unknown date.According to the complainant, it was noted that the end was broken, it snapped and could not be used.Additional information received on 03may2019.The procedure was completed with another rx cytology brush.The patient condition following the procedure was reported to be stable.

Manufacturer Narrative

Date of event: date of event was approximated to be (b)(6) 2019 as no event date was reported.Device problem code 1069 captures the reportable event of wire broken.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".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 has been updated based on additional information received on may 03, 2019.

• 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: 8573447
• MDR Text Key: 143832199
• Report Number: 3005099803-2019-02292
• 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: 05/24/2019

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: 06/25/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0022302908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1