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 2018-10-08 for CELLEBRITY M00516071 54775 manufactured by Boston Scientific Corporation.
[123076990]
The patients exact age was not reported, however the patient was reported to be over the age of 18. (b)(4). The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. The health care facility address is (b)(6). (b)(4). Investigation results: a cellebrity cytology brush was returned for evaluation. A visual analysis of the returned device revealed that it had sheath damage. It was received in closed/retracted position and the yellow sheath was detached from the handle and its proximal section was torn. There were no other anomalies noted. A functional inspection was performed and found that the brush could not be opened/extended probably due to the section of the sheath found damaged (detached and torn). The failure found (yellow sheath detached and torn) is an issue that could have been generated by excessive manipulation of the device by the user and/or excess of force applied to the product; once the sheath has been damaged it will affect the functionality of the device since this type of defect does not allow the device to perform its function to move backward / forward as is expected; hence, the brush section cannot be extended or retracted properly. Therefore, it was concluded that the investigation conclusion code for this event is "cause traced to component failure" since the failure was an expected or random component failure without any design or manufacturing issue. 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
[123076991]
It was reported to boston scientific corporation that a cellebrity cytology brush was used during a procedure performed in (b)(6) 2018. According to the complainant, during the procedure, after performing cytology, the sheath got torn causing the brush to not extend smoothly. The procedure was completed with another cellebrity cytology brush. There were no patient complications reported as a result of this event. The patient condition following 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 working length was detached/separated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-60776 |
| MDR Report Key | 7945650 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-08 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-09-16 |
| Date Added to Maude | 2018-10-08 |
| 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 | CELLEBRITY |
| Generic Name | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BTG |
| Date Received | 2018-10-08 |
| Returned To Mfg | 2018-08-28 |
| Model Number | M00516071 |
| Catalog Number | 54775 |
| 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 | 2018-10-08 |