MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-20 for CELLEBRITY? M00516151 1615 manufactured by Boston Scientific - Spencer.
[3436552]
It was reported to boston scientific corporation that a cellebrity cytology brush was used during a bronchoscopy procedure performed on (b)(6) 2013. According to the complainant, during the procedure, the brush would not expel through the scope due to malfunction. The brush was kinked at the top, keeping the brush from coming through. 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 stable.
Patient Sequence No: 1, Text Type: D, B5
[10515900]
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[19997570]
It was reported to boston scientific corporation that a cellebrity cytology brush was used during a bronchoscopy procedure performed on (b)(6) 2013. According to the complainant, during the procedure, the brush would not expel through the scope due to malfunction. The brush was kinked at the top, keeping the brush from coming through. 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 stable.
Patient Sequence No: 1, Text Type: D, B5
[20410876]
Visual evaluation of the returned device found that the working length of the device (both sheath and wire) was kinked and buckled in several locations. Functional evaluation found that when the handle was actuated, the working length bunched up due to the kinks in the working length. The brush would not extend without assistance. However, the brush would retract without issue. The brush was attached to the rest of the device and was not bent. Based on the investigation finding that the brush was not bent, this is no longer considered a reportable event. Review and analysis of all available information indicated the most probable root cause for this event was operational/physiological context. A search of the complaint database revealed that no other complaints exist for the specified lot. The device history record review found the device met all manufacturing specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2013-01099 |
| MDR Report Key | 2969839 |
| Report Source | 05,07 |
| Date Received | 2013-02-20 |
| Date of Report | 2013-01-30 |
| Date of Event | 2013-01-10 |
| Date Mfgr Received | 2013-03-15 |
| Device Manufacturer Date | 2012-01-28 |
| Date Added to Maude | 2013-02-20 |
| 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. CHARLES MONTGOMERY |
| 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 | 2013-02-20 |
| Returned To Mfg | 2013-02-22 |
| Model Number | M00516151 |
| Catalog Number | 1615 |
| Lot Number | 14991274 |
| Device Expiration Date | 2014-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2013-02-20 |