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 2019-04-23 for RX CYTOLOGY BRUSH M00545000 4500 manufactured by Boston Scientific Corporation.
[142779070]
Date of event was approximated to be (b)(6) 2019 as no event date was reported. (b)(6). (b)(4). An rx cytology brush was returned for analysis. A visual analysis of the returned device revealed that the working length (extrusion and pull wire) was kinked in several locations. The handle was separated from the device. The pull wire was kinked and broken adjacent to the handle cannula joint. In addition, the distal section of the pull wire was extended and it was observed that the brush section was cut at distal end, marks in the cut ends of the wire indicated that an unknown tool was used to cut the device. Functional inspection was performed and the pull wire failed to retract. It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity. Likely the failures found (pull wire/extrusion kinked/broken, handle separated) were caused due to manipulation as the customer brushed back and forth during procedure. Handling and manipulation of the device can lead to kinking of the extrusion and pull wire. This condition can cause difficulties to extend/retract the brush. Force applied to the handle in order to extend/retract the brush can result in kinking the pull wire at handle cannula joint, also continued movements of the handle to extend/retract the brush can result in pull wire breakage and consequently the handle separation from the device. Based on the information available and the analysis performed, the most probable root cause 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
[142779071]
It was reported to boston scientific corporation that an rx cytology brush wireguided was used in the bile duct during a cytology procedure performed on an unknown date. According to the complainant, during the procedure, after scraping was performed and when the brush was retracted into the catheter, the brush was unable to retract. The procedure was completed with another rx cytology brush. There were no patient complications reported as a result of this event. Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the wire was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02115 |
| MDR Report Key | 8540441 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2018-09-28 |
| Date Added to Maude | 2019-04-23 |
| 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 | 2019-04-23 |
| Returned To Mfg | 2019-03-18 |
| Model Number | M00545000 |
| Catalog Number | 4500 |
| Lot Number | 0022698146 |
| 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 | 2019-04-23 |