MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-05-27 for CELLEBRITY? M00516151 1615 manufactured by Boston Scientific - Spencer.
[4498734]
It was reported to boston scientific corporation that a celebrity cytology brush was used during a bronchoscopy procedure performed on (b)(6)2014. According to the complainant, during the procedure, the brush would bend during brushing because it was not rigid enough. A second celebrity cytology brush was used to complete the procedure, since the user was unable to extend the brush back out of the sheath. 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.
Patient Sequence No: 1, Text Type: D, B5
[11814440]
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown. However, the complainant stated that the device was used prior to the expiration date. Reported event: brush bent. 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
[32689311]
Visual evaluation of the returned product found device to be retracted and covered with residue. The catheter and the drive wire were bent in multiple places, which prevented the brush from extending during functional testing. However, the brush was able to extend when the catheter was held taut. At this time, it was noted that the brush was not bent. The condition of the returned device was not consistent with the complaint that the brush was bent; however, the complaint that the brush was difficult to extend was confirmed. Tortuous anatomy and other operational factors can cause the working length to bend. Once the working length is bent, it would be difficult to actuate the brush. Therefore, the most probable root cause for the identified failures is operational context.
Patient Sequence No: 1, Text Type: N, H10
[32689312]
It was reported to boston scientific corporation that a celebrity cytology brush was used during a bronchoscopy procedure performed on (b)(6) 2014. According to the complainant, during the procedure, the brush would bend during brushing because it was not rigid enough. A second celebrity cytology brush was used to complete the procedure, since the user was unable to extend the brush back out of the sheath. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2014-02074 |
| MDR Report Key | 3833584 |
| Report Source | 05,07 |
| Date Received | 2014-05-27 |
| Date of Report | 2014-04-29 |
| Date of Event | 2014-04-29 |
| Date Mfgr Received | 2014-07-11 |
| Date Added to Maude | 2014-05-27 |
| 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. INGRID MATTE |
| 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 | 2014-05-27 |
| Returned To Mfg | 2014-06-03 |
| Model Number | M00516151 |
| Catalog Number | 1615 |
| 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 | 2014-05-27 |