N
Patient 1
(B)(4). 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.
MAUDE MDR 7436223
- MDR report key
- 7436223
- Report number
- 3005099803-2018-01104
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-03-26
- Date received
- 2018-04-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- EMP. NANCY CUTINO
- Address
- 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
- Phone
- 508-508-5086
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CELLEBRITY? | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) | BOSTON SCIENTIFIC - SPENCER | BTG | M00516011 | 1601 | 21287228 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-04-17 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BRONCHOSCOPY WITH BRUSHING PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRISTLED PORTION OF THE BRUSH WAS BENT AND IT WAS NOTICED THAT THE DEVICE WAS DIFFICULT TO ADVANCE THROUGH THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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.