MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-06-01 for CYTOLOGY BRUSH M00516010 1601S manufactured by Boston Scientific - Spencer.
[2642445]
Note: this report pertains to one of three devices used during the same procedure. Manufacturer report #s 3005099803-2012-02056 and 3005099803-2012-02058 address the other devices. It was reported to boston scientific corporation that three celebrity cytology brushes were used during a bronchoscopy procedure performed on (b)(6), 2012. According to the complainant, the technician was unable to retract any of the three brushes back into their respective sheaths after obtaining samples from the patient's trachea. However, after this issue occurred with the third brush, it was determined that the samples obtained with these brushes were adequate and the procedure was concluded. 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
[9928639]
Exact patient age is unknown but is over 18 years. The complainant was unable to provide the suspect device lot number; therefore, the device expiration and device manufactured dates are unknown. (b)(4) brush failed to retract. 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 | 3005099803-2012-02057 |
| MDR Report Key | 2596001 |
| Report Source | 05,07 |
| Date Received | 2012-06-01 |
| Date of Report | 2012-05-11 |
| Date of Event | 2012-05-11 |
| Date Mfgr Received | 2012-05-11 |
| Date Added to Maude | 2012-06-01 |
| 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 | CYTOLOGY BRUSH |
| Generic Name | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BTG |
| Date Received | 2012-06-01 |
| Model Number | M00516010 |
| Catalog Number | 1601S |
| Operator | OTHER |
| 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 | 2012-06-01 |