MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-06-06 for CELLEBRITY? M00516151 1615 manufactured by Boston Scientific - Spencer.
[46664705]
(b)(4). Investigation result: analysis of the returned cellebrity cytology brush revealed multiple bends in the working length and pull wire. The wire had been broken at the end of the hypotube. The catheter was torn/ split from the luer cap, which made the handle cannula poke through a tear when handle spool was actuated. The brush bristle section was present, properly formed, and without issue. Functional analysis showed that the brush would not extend due to wire broke. The event was most likely caused by some operational or anatomical aspect of the procedure which restricted the pull wire? S ability to move freely within the catheter. Attempts to extend and retract the brush with pull wire movement restricted resulted in the broken pull wire. Therefore, the most probably root cause for this event is determined to be operational context. A review of the device history record (dhr) was performed and no deviations were found.
Patient Sequence No: 1, Text Type: N, H10
[46664706]
It was reported to boston scientific corporation that a cellebrity cytology brush was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2016. According to the complainant, during the procedure, the plastic sheath kinked. 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. This event has been deemed a reportable event based on the investigation results; wire broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2016-01529 |
| MDR Report Key | 5701946 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-06 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-03-24 |
| Date Mfgr Received | 2016-05-12 |
| Device Manufacturer Date | 2015-11-05 |
| Date Added to Maude | 2016-06-06 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 2016-06-06 |
| Returned To Mfg | 2016-04-13 |
| Model Number | M00516151 |
| Catalog Number | 1615 |
| Lot Number | 18590449 |
| Device Expiration Date | 2017-11-30 |
| 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 | 2016-06-06 |