MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-08-02 for NBCA LIQUID EMBOLIC SYSTEM 2 631500 manufactured by Cordis Neurovascular, Inc..
[2130885]
The report received from the field indicated that the physician opened and mixed the n-bca liquid embolic system and ethiodized oil. The physician inspected the mixture and bubbles were noted that would not disperse. The physician felt that the mixture of the glue and oil was not complete and discarded the mixture. The product was not clinically used in the patient. There was no reported patient injury. A new kit was used. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[9278216]
(b)(4). The product is not available for evaluation and testing. Additional information will be submitted within 30 days upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[9398175]
After mixing the (b)(4), the mixture had bubbles in it and would not disburse. It was felt that the mixture of glue and oil was not complete. The mixture was discarded and a new kit was used with no reported patient injury. No further information regarding the mixture is available. The product was not returned for inspection. A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. Review of lot 453484 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. No units were rejected during the final assembly of this lot and there were no non-conformances or process monitory excursions for this lot. No other issues were noted that were considered potentially related to the reported complaint. Based on the available information, no conclusion can be made. Based on the device history records review there is no indication of a relationship to the manufacturing process. Therefore, no corrective actions will be taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1058196-2011-00395 |
| MDR Report Key | 2186801 |
| Report Source | 05,07 |
| Date Received | 2011-08-02 |
| Date of Report | 2011-07-07 |
| Date of Event | 2011-07-06 |
| Date Mfgr Received | 2011-07-25 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2011-09-30 |
| 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 | MR. LINA ALZATE |
| Manufacturer Street | 14700 NW 57TH COURT |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863136492 |
| Manufacturer G1 | CORDIS CORPORATION |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NBCA LIQUID EMBOLIC SYSTEM 2 |
| Generic Name | CNV_NBCA (MFE) |
| Product Code | KGG |
| Date Received | 2011-08-02 |
| Model Number | NA |
| Catalog Number | 631500 |
| Lot Number | 453484 |
| ID Number | NA |
| Device Expiration Date | 2013-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS NEUROVASCULAR, INC. |
| Manufacturer Address | 14700 NW 57TH COURT MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-02 |