MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-10 for RX CYTOLOGY BRUSH M00545000 4500 manufactured by Boston Scientific Corporation.
[141575146]
Investigation results: an rx cytology brush was returned for analysis. A visual evaluation of the returned device revealed that the brush was extended when received. The working length (extrusion and pull wire) was kinked in several locations. Additionally, the distal section of the device (brush section) was kinked. No other anomalies were noted. Handling and manipulation of the device during its use can lead to kinking/bending of the device in several locations, including the distal section. Also interaction with the scope could have contributed with the reported event, since the device could have been hit against the scope while it was being introduced. This could have kinked/bent the device. Based on the information available and the analysis performed, the most probable root cause classification for this event is adverse event related to procedure. 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.
Patient Sequence No: 1, Text Type: N, H10
[141575147]
It was reported to boston scientific corporation that an rx cytology brush wireguided was opened for use in the bile duct during a diagnostic procedure performed on (b)(6) 2019. According to the complainant, prior to the procedure, when the device was introduced into the working channel, it was noted that the catheter was bent. The procedure was completed with another rx 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 fine. Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the bristled portion of the brush was bent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01836 |
| MDR Report Key | 8500996 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-10 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-03-26 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RX CYTOLOGY BRUSH |
| Generic Name | ENDOSCOPIC CYTOLOGY BRUSH |
| Product Code | FDX |
| Date Received | 2019-04-10 |
| Returned To Mfg | 2019-03-11 |
| Model Number | M00545000 |
| Catalog Number | 4500 |
| Lot Number | 22967996 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |