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 2019-04-03 for RX CYTOLOGY BRUSH M00545000 4500 manufactured by Boston Scientific Corporation.
[140880036]
Investigation results: an rx cytology brush was returned for analysis. A visual analysis of the returned device revealed that the brush was partially retracted when received. The working length (pull wire and extrusion) was kinked in several locations and the distal end of the pull wire (tip of the brush) was also bent. A functional inspection revealed that the device was unable to extend and retract when the handle was actuated. A dimensional inspection was also performed and the device was measured and found to be within manufacturing specifications. No other issue was noted. The failures found (working length and brush tip kinked) are issues that could have been generated during the manipulation of the device by the user; once this section of the unit has been damaged it can affect its functionality since these types of defects do not allow the product to perform its function to move backward / forward; hence, the brush section would not extend or retract properly. The kinked condition of the device also could have been the cause of the issues to advance 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
[140880037]
It was reported to boston scientific corporation that an rx cytology brush wireguided was used in the common bile duct during a cytology procedure performed on (b)(6) 2019. According to the complainant, during the procedure, when retracting the brush into the catheter prior to being inserted into the endoscope, it was noted that the tip was unable to completely retract even when the handle was pulled to the end. When it was inserted into the endoscope along with the guidewire, the brush was unable to advance inside the bile duct and the brush could not be manipulated. 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 bristled portion of the brush was bent/kinked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01587 |
| MDR Report Key | 8479896 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2018-10-24 |
| Date Added to Maude | 2019-04-03 |
| 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 | 2019-04-03 |
| Returned To Mfg | 2019-02-21 |
| Model Number | M00545000 |
| Catalog Number | 4500 |
| Lot Number | 22775188 |
| 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 | 2019-04-03 |