MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-06-27 for CELLEBRITY? M00516151 1615 manufactured by Boston Scientific - Spencer.
[16626533]
(b)(4): visual evaluation of the returned device found that the brush wire assembly had broken at the distal end of the handle cannula, and the working length was kinked and buckled in several locations. The outer sheath was torn approximately 4. 5cm from the distal end of the handle cap, and the wire protruded from the tear. The brush was not present. The condition of the returned device was consistent with the complaint that the working length was kinked, the pull wire broke, and the wire was protruding through the sheath; the complaint was confirmed. The most probable root cause of the defects identified is operational context. A review of the device history record (dhr) was performed; no anomalies were noted.
Patient Sequence No: 1, Text Type: N, H10
[16676842]
Note: this report pertains to one of three devices used during the same procedure. Manufacturer report #s 3005099803-2012-02428 and 3005099803-2012-02429 address the other devices. It was reported to boston scientific corporation that three cellebrity cytology brushes were used during a bronchoscopy procedure performed on (b)(6), 2012. According to the complainant, the pull wires of all three devices broke near their respective handles, and the wires were protruding through the sheaths. It was also reported that the working lengths of all three devices were kinked. As none of the brushes could be extended into the patient's bronchus, the procedure was completed with another cellebrity cytology brush. It was confirmed that the user removed all three bristle brushes prior to returning the products. There were no patient complications reported as a result of this event. The patient's condition was reported to be fine following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2012-02329 |
| MDR Report Key | 2630153 |
| Report Source | 05,07 |
| Date Received | 2012-06-27 |
| Date of Report | 2012-05-29 |
| Date of Event | 2012-05-22 |
| Date Mfgr Received | 2012-05-29 |
| Device Manufacturer Date | 2012-02-13 |
| Date Added to Maude | 2012-06-27 |
| 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 | 2012-06-27 |
| Returned To Mfg | 2012-06-01 |
| Model Number | M00516151 |
| Catalog Number | 1615 |
| Lot Number | 15024182 |
| Device Expiration Date | 2014-02-09 |
| Operator | PHYSICIAN |
| 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 | 2012-06-27 |