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 2017-03-30 for CELLEBRITY? M00516151 1615 manufactured by Boston Scientific - Spencer.
[71276394]
(b)(4). Investigation results: visual evaluation of the returned device revealed that the sheath was separated and torn at the proximal end. It was found that the catheter was kinked in multiple locations throughout. Functional analysis showed that the device handle moved smoothly in both directions, however, the brush failed to extend due to sheath was separated. Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited. Therefore, the most probable root cause classification for the reported failure is operational context. A review of the device history record (dhr) was performed and no deviations were found. A search of the complaint database revealed that no other complaints exist for the specified lot.
Patient Sequence No: 1, Text Type: N, H10
[71276395]
It was reported to boston scientific corporation that a cellebrity cytology brush was used during a procedure performed on (b)(6) 2017. According to the complainant, during the procedure, the brush failed to extend. The procedure was completed with another cellebrity brush. There were no known patient complications reported as a result of this event. This event has been deemed a reportable event based on the investigation results; sheath was separated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-00812 |
| MDR Report Key | 6446604 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-30 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-02-13 |
| Date Mfgr Received | 2017-03-09 |
| Device Manufacturer Date | 2016-12-09 |
| Date Added to Maude | 2017-03-30 |
| 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 | 2017-03-30 |
| Returned To Mfg | 2017-02-23 |
| Model Number | M00516151 |
| Catalog Number | 1615 |
| Lot Number | 20048635 |
| Device Expiration Date | 2018-12-31 |
| Operator | NURSE |
| 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 | 2017-03-30 |