MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-09-23 for CELLEBRITY? M00516011 1601 manufactured by Boston Scientific - Spencer.
[4922181]
It was reported to boston scientific corporation that a celebrity cytology brush was used in the lungs during a lung biopsy procedure performed on (b)(6) 2014. According to the complainant, during the procedure, an excelon needle and a brush failed to obtain a tissue sample, the needle failed to flush and the brush failed to extend. The procedure was completed with another celebrity cytology brush. 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 fine. This event has been deemed a reportable event based on the investigation results: catheter torn.
Patient Sequence No: 1, Text Type: D, B5
[12370457]
Investigation results finding the catheter torn. Investigation results: visual evaluation of the returned device found the working length was bent and brush was retracted. Functional evaluation performed, the brush was attempted to be extended but failed due to the tear in the catheter, but the strain relief was still connected to the handle. The condition of the returned device was consistent with the complaint that the brush was difficult to extend; the complaint was confirmed. The proximal part of the catheter was torn but the strain relief remained intact. Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context. A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.? A search of the complaint database confirmed that no other complaints exist for the specified batch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2014-03138 |
| MDR Report Key | 4111811 |
| Report Source | 05,07 |
| Date Received | 2014-09-23 |
| Date of Report | 2014-08-31 |
| Date of Event | 2014-07-28 |
| Date Mfgr Received | 2014-08-31 |
| Device Manufacturer Date | 2014-04-07 |
| Date Added to Maude | 2014-09-23 |
| 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 | 2014-09-23 |
| Returned To Mfg | 2014-08-01 |
| Model Number | M00516011 |
| Catalog Number | 1601 |
| Lot Number | 16871287 |
| Device Expiration Date | 2016-04-03 |
| 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 | 2014-09-23 |