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 2017-12-06 for CELLEBRITY? M00516011 1601 manufactured by Boston Scientific - Spencer.
[94833401]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(4). Investigation results: visual evaluation of the returned celebrity cytology brush revealed that the catheter was kinked and torn near to the handle. Further evaluation noted that the pull wire was found kinked and broken with evidence of bending. Functional analysis showed that the brush failed to extend due to the condition of the returned device. Based on the evaluation of the returned device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device. Therefore, the most probable root cause is operational context. A review of the device history record (dhr) was performed and no deviations were found.
Patient Sequence No: 1, Text Type: N, H10
[94833402]
It was reported to boston scientific corporation that a celebrity cytology brush was used in the lungs during a bronchoscopy procedure. According to the complainant, during the procedure, the catheter was kinked and the brush failed to extend and retract. The procedure was completed with another celebrity cytology brush. The patient's condition at the conclusion of the procedure was reported to be stable. This event has been deemed a reportable event based on the investigation results; wire broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-03503 |
| MDR Report Key | 7087270 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-06 |
| Date of Report | 2017-11-10 |
| Date Mfgr Received | 2017-11-10 |
| Device Manufacturer Date | 2017-03-22 |
| Date Added to Maude | 2017-12-06 |
| 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 | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - SPENCER |
| 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 | 2017-12-06 |
| Returned To Mfg | 2017-10-27 |
| Model Number | M00516011 |
| Catalog Number | 1601 |
| Lot Number | 20420907 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-06 |