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 2015-07-24 for CELLEBRITY? M00516071 1607 manufactured by Boston Scientific - Spencer.
[6435050]
It was reported to boston scientific corporation that a celebrity cytology brush was used in the procedure. According to the complainant, the brush got stuck when it was released from the bronchi. Consequently, they had a difficulty in taking a sample. After the device was withdrawn, the plastic sheath was noted to be shriveled and brush was kinked. The device failed to close and was unable to take a second sample.
Patient Sequence No: 1, Text Type: D, B5
[13514591]
Reported event of brush bent. According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2015-02006 |
| MDR Report Key | 4939196 |
| Report Source | 00,01,05,07 |
| Date Received | 2015-07-24 |
| Date of Report | 2015-06-30 |
| Date Mfgr Received | 2015-06-30 |
| Device Manufacturer Date | 2014-02-14 |
| Date Added to Maude | 2015-07-24 |
| 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 | 2015-07-24 |
| Model Number | M00516071 |
| Catalog Number | 1607 |
| Lot Number | 0016739924 |
| Device Expiration Date | 2016-02-13 |
| 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 | 2015-07-24 |