MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 2015-01-13 for FASTRACKER? - 325 SYSTEM M0035503040 550304 manufactured by Boston Scientific - Cork.
[5277978]
Reportable based on device analysis completed on 15dec2014. It was reported that inner package damage occurred. During unpacking, the physician noted that the inner package of the fastracker? - 325 system was damaged. The procedure was completed with another of the same device. There were no patient complications reported and the patient? S condition was stable. However, device analysis revealed that the top seal of the inner pouch had been opened.
Patient Sequence No: 1, Text Type: D, B5
[12718993]
The complaint device was returned for analysis. Clear tape had been applied on both the top and bottom openings of the box. On opening the box it could be seen that the pouch was open at the top. The pouch was removed from the box and it could be seen that the seal at the top of the pouch had been opened and that the rest of the seal around the package was intact. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134265-2015-00196 |
| MDR Report Key | 4413966 |
| Report Source | 01,05,07,08 |
| Date Received | 2015-01-13 |
| Date of Report | 2014-12-15 |
| Date of Event | 2014-09-26 |
| Date Mfgr Received | 2014-12-15 |
| Device Manufacturer Date | 2012-11-14 |
| Date Added to Maude | 2015-01-13 |
| 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. LINDA LEIMER |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - CORK |
| Manufacturer Street | BUSINESS AND TECHNOLOGY PARK MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FASTRACKER? - 325 SYSTEM |
| Generic Name | AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS |
| Product Code | NAJ |
| Date Received | 2015-01-13 |
| Returned To Mfg | 2014-10-13 |
| Model Number | M0035503040 |
| Catalog Number | 550304 |
| Lot Number | 15627877 |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - CORK |
| Manufacturer Address | BUSINESS AND TECHNOLOGY PARK MODEL FARM ROAD CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-13 |