MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2015-01-05 for CELLEBRITY? M00516001 1600 manufactured by Boston Scientific - Spencer.
[5239616]
It was reported to boston scientific corporation that a celebrity cytology brush was used during a bronchoscopy procedure performed on (b)(6) 2014. According to the complainant, during the procedure, it was noted that the distal end of the brush had a dent. The procedure was completed with a second celebrity cytology brush was used to complete the procedure. 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
Patient Sequence No: 1, Text Type: D, B5
[12613842]
Reported event: brush bent. The complainant indicated that the device was discarded and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2014-04069 |
| MDR Report Key | 4381097 |
| Report Source | 00,01,05,07 |
| Date Received | 2015-01-05 |
| Date of Report | 2014-12-08 |
| Date of Event | 2014-12-08 |
| Date Mfgr Received | 2014-12-08 |
| Device Manufacturer Date | 2014-01-27 |
| Date Added to Maude | 2015-01-05 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 2015-01-05 |
| Model Number | M00516001 |
| Catalog Number | 1600 |
| Lot Number | 16686885 |
| Device Expiration Date | 2016-01-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-01-05 |