MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2012-03-23 for CELLEBRITY? M00516001 1600 manufactured by Boston Scientific - Spencer.
[2578059]
It was reported to boston scientific corporation that a cellebrity cytology brush was used during a biopsy procedure performed on (b)(6) 2012. According to the complainant, the device broke inside the scope. The procedure was completed with this 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 "okay. "
Patient Sequence No: 1, Text Type: D, B5
[2690317]
It was reported to boston scientific corporation that a celebrity cytology brush was used during a biopsy procedure performed on (b)(6), 2012. According to the complainant, the device broke inside the scope. The procedure was completed with this 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 "okay. "
Patient Sequence No: 1, Text Type: D, B5
[9771606]
(b)(4) for the reported event: brush broke. The complaint device has been received by the manufacturer; however, a failure analysis has not yet been completed. Upon receipt of the failure analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[9967557]
Visual evaluation of the returned device found the outer sheath to be kinked at the distal end. The outer sheath had detached from the handle, but the clear strain relief remained attached and it was also kinked at the distal end. Less than two threads were visible at the proximal end of the handle cap, and indentations were found on the outer sheath to indicate the cap was tightened during manufacturing. The outer sheath was removed from the drive wire. The drive wire, which was still attached to the handle, was kinked in several locations. The device handle functioned smoothly. The condition of the returned device was consistent with the complaint that the device broke; 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. A search of the complaint database revealed that no other complaints exist for the specified lot. It was initially reported that the device broke and, since the customer was unable to provide clarification of the damage to the device, the event was considered mdr-reportable. However, the investigation found that the outer sheath was detached from the handle outside the patient. The event is no longer considered mdr-reportable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2012-01059 |
| MDR Report Key | 2501675 |
| Report Source | 00,01,05,07 |
| Date Received | 2012-03-23 |
| Date of Report | 2012-02-29 |
| Date of Event | 2012-02-23 |
| Date Mfgr Received | 2012-04-03 |
| Device Manufacturer Date | 2011-05-02 |
| Date Added to Maude | 2012-03-23 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | 2012-03-23 |
| Returned To Mfg | 2012-03-15 |
| Model Number | M00516001 |
| Catalog Number | 1600 |
| Lot Number | 14328351 |
| Device Expiration Date | 2013-05-01 |
| 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 | 2012-03-23 |