MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-10-28 for CELLEBRITY? M00516011 1601 manufactured by Boston Scientific - Spencer.
[58718288]
(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 Sequence No: 1, Text Type: N, H10
[58718289]
It was reported to boston scientific corporation that a cellebrity cytology brush was used during a cytology procedure performed on (b)(6) 2016. According to the complainant, during the procedure, the working length was completely detached from the handle. 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 good.
Patient Sequence No: 1, Text Type: D, B5
[61673959]
Investigation results: analysis of the returned cellebrity cytology brush revealed that the flare was detached. Visual assessment found the plastic sheath was detached from the handle. The catheter was torn and the pull wire was kinked at the proximal area. The handle or cannula was within specification. Functional evaluation could not be performed due to flare detachment. 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 the specified lot.
Patient Sequence No: 1, Text Type: N, H10
[61673960]
It was reported to boston scientific corporation that a cellebrity cytology brush was used during a cytology procedure performed on (b)(6) 2016. According to the complainant, during the procedure, the working length was completely detached from the handle. 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 good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2016-03238 |
| MDR Report Key | 6064690 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-28 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-10-03 |
| Date Mfgr Received | 2016-11-14 |
| Device Manufacturer Date | 2016-01-08 |
| Date Added to Maude | 2016-10-28 |
| 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 | 2016-10-28 |
| Returned To Mfg | 2016-10-13 |
| Model Number | M00516011 |
| Catalog Number | 1601 |
| Lot Number | 18782689 |
| Device Expiration Date | 2018-01-31 |
| Operator | PHYSICIAN |
| 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 | 2016-10-28 |