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 CYTOLOGY BRUSH UNK349 manufactured by Boston Scientific - Spencer.
[15359190]
It was reported to boston scientific corporation that a celebrity cytology brush was used during a bronchoscopy procedure. 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.
Patient Sequence No: 1, Text Type: D, B5
[15664899]
The complainant was unable to report the upn and 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 complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2014-02076 |
| MDR Report Key | 3833587 |
| Report Source | 05,07 |
| Date Received | 2014-05-27 |
| Date of Report | 2014-04-29 |
| Date Mfgr Received | 2014-04-29 |
| 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 | CYTOLOGY BRUSH |
| Generic Name | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BTG |
| Date Received | 2014-05-27 |
| Model Number | UNK349 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |