| 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 | M00516151 | 1615 | 19301691 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-08-18 | 0 |
Patient 1
(B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CYTOLOGY BRUSH WAS USED TO ADVANCE INTO THE BRONCHOSCOPE. THE HANDLE WAS MANIPULATED TO ACTUATE THE BRUSH AND NOTICED THAT THE DEVICE WAS BEYOND THE VISUAL RANGE OF THE BRONCHOSCOPE, THEREFORE, IT WAS DIFFICULT TO MOVE THE DEVICE IN AND OUT. THEY PULLED THE BRUSH OUT; IT WAS FOUND THAT THE PLASTIC SHEATH WAS TORN OR SPLIT AND THE WIRE INSIDE THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CELLEBRITY 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.
Patient 1
(B)(4). ? VISUAL EVALUATION OF THE RETURNED DEVICE HAS THE CATHETER SPLIT/TORN AND THE PULL WIRE WAS BROKEN FROM THE PROXIMAL END. THE WORKING LENGTH WAS KINKED AND THE HANDLE OR HANDLE CANNULA HAS NO ISSUE AND WAS WITHIN SPECIFICATION. DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE; PERFORMANCE OF THE DEVICE WAS LIMITED. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE REPORTED FAILURE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATIONS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THIS SPECIFIED LOT.
Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CYTOLOGY BRUSH WAS USED TO ADVANCE INTO THE BRONCHOSCOPE. THE HANDLE WAS MANIPULATED TO ACTUATE THE BRUSH AND NOTICED THAT THE DEVICE WAS BEYOND THE VISUAL RANGE OF THE BRONCHOSCOPE, THEREFORE, IT WAS DIFFICULT TO MOVE THE DEVICE IN AND OUT. THEY PULLED THE BRUSH OUT; IT WAS FOUND THAT THE PLASTIC SHEATH WAS TORN OR SPLIT AND THE WIRE INSIDE THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CELLEBRITY 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.