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 2019-05-02 for RX CYTOLOGY BRUSH M00545000 4500 manufactured by Boston Scientific Corporation.
[143854214]
(b)(6). (b)(4). Investigation results: an rx cytology brush was returned for analysis. A visual analysis of the device revealed that the brush was extended when received. The working length (extrusion and pull wire) was kinked/bent near the handle. A functional evaluation was performed and revealed that when the handle was actuated, the brush was unable to retract. The device was disassembled and it was observed that the pull wire was kinked and broken adjacent to the handle cannula joint. No other anomalies were noted. 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/catheter kinked/bent, pull wire bent and broken) were caused due to excessive manipulation as the customer brushed back and forth during procedure. Handling and manipulation of the device can lead to kinking of the catheter and pull wire. This condition can cause difficulties to extend/retract the brush, excessive force applied to the handle in order to extend/retract the brush can result in kinking of the pull wire at handle cannula joint. Also continued movements of the handle can result in pull wire breakage. 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
[143854215]
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 (b)(6) 2019. According to the complainant, during the procedure, the brush failed to retract. When the device was visually inspected, the working length was noted to be kinked. The procedure was then completed with another rx cytology brush. 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. This event has been deemed an mdr reportable event based on the investigation results which revealed that the pull wire was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02330 |
| MDR Report Key | 8573860 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2019-01-04 |
| Date Added to Maude | 2019-05-02 |
| 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 | 2019-05-02 |
| Returned To Mfg | 2019-04-03 |
| Model Number | M00545000 |
| Catalog Number | 4500 |
| Lot Number | 0023112331 |
| 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 | 2019-05-02 |