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 2019-03-26 for RX CYTOLOGY BRUSH M00545000 4500 manufactured by Boston Scientific Corporation.
[139839874]
(b)(6). (b)(4). The device has been received for analysis; however the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[139839875]
It was reported to boston scientific corporation that an rx cytology brush wireguided was used to diagnose a cholangiocarcinoma in the bile duct during a scraping cytology procedure performed on (b)(6) 2019. According to the complainant, during the procedure, when starting to scrape for tissue sample, severe resistance was felt, so the device was removed. Upon checking, the tip was found to be bent. The procedure was completed with another rx cytology brush. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01412 |
| MDR Report Key | 8451763 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-26 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2018-10-24 |
| Date Added to Maude | 2019-03-26 |
| 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 | 2019-03-26 |
| Returned To Mfg | 2019-03-18 |
| Model Number | M00545000 |
| Catalog Number | 4500 |
| Lot Number | 0022775188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-26 |