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 2017-01-03 for CELLEBRITY? M00516071 1607 manufactured by Boston Scientific - Spencer.
[63799857]
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. (b)(4). Investigation results: detailed analysis of the returned cellebrity cytology brush revealed that the catheter was separated and was kinked at the proximal end. The damage to the returned device was most likely due to operational/physiological context issues encountered during the procedure. Therefore, the root cause for this event is most likely determined to be operational context.
Patient Sequence No: 1, Text Type: N, H10
[63799858]
It was reported to boston scientific corporation that a cellebrity cytology brush was used in a procedure performed on (b)(6) 2016. According to the complainant, during the procedure, the plastic sheath torn or split. The procedure was not completed due to this event. There were no patient complications reported as a result of this event. 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; flare detached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2016-03982 |
| MDR Report Key | 6220088 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-03 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-08-15 |
| Date Mfgr Received | 2016-12-13 |
| Date Added to Maude | 2017-01-03 |
| 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 | 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 | 2017-01-03 |
| Returned To Mfg | 2016-12-01 |
| Model Number | M00516071 |
| Catalog Number | 1607 |
| 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 | 2017-01-03 |