RX CYTOLOGY BRUSH
Received May 2, 2019 · Event occurred May 1, 2019
Report 3005099803-2019-02292 · MDR key 8573447
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
0022302908
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional 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.
Description of Event or Problem
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.
Description of Event or Problem
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.
Additional 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.