MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2006-07-27 for EXELON TBA * 6410 manufactured by Boston Scientific.
[524204]
The complainant has reported that a pt (age and gender unk) underwent a diagnostic transbronchial needle aspiration for biopsy in 2006. They successfully advanced the catheter to the channel of the scope but were not able to take the biopsy because "the front part of the needle was broken". There was no reported complication or ill effect sustained by the pt.
Patient Sequence No: 1, Text Type: D, B5
[7842821]
This device has not been received by this mfr. An evaluation has not yet been performed. Therefore, a failure analysis is not available and we are unable to determine if the device met its specifications. Should further relevant details become available; a supplemental medwatch report will be filed under the appropriate sequence number. We are unalble to determine the relationship between this device and the cause for this event at this time. Our directions for use outline appropriate placement. Access and maintenance procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000048-2006-00391 |
| MDR Report Key | 746041 |
| Report Source | 01,05,06,07 |
| Date Received | 2006-07-27 |
| Date of Report | 2006-07-12 |
| Date of Event | 2006-07-10 |
| Date Mfgr Received | 2006-07-12 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-08-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | BOSTON SCIENTIFIC |
| Manufacturer Street | 780 BROOKSIDE DR |
| 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 | EXELON TBA |
| Generic Name | TRANSBRONCHIAL ASPIRATION NEEDLE |
| Product Code | NNC |
| Date Received | 2006-07-27 |
| Model Number | * |
| Catalog Number | 6410 |
| Lot Number | 8603892 |
| ID Number | * |
| Device Expiration Date | 2009-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 733829 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 780 BROOKSIDE DR. SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-27 |