MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-11-20 for NBCA LIQUID EMBOLIC SYSTEM 2 631500 manufactured by Cordis Neurovascular, Inc..
[3046492]
Pediatric patient treated and discharged with a small rash on his feet. The patient developed a fever and was re-admitted to the hospital. Patient was referred to allergist upon request from his mother. Rep received phone call to alert of the incident on and requested a sample kit for evaluation. Evaluation kit for allergist, under supervision of physician sent to hospital via representative. (b)(4), lot 268818. No date established yet for test. Update will be provided as soon as they are available. Additional information received indicated that the patient was treated with one kit of nbca glue for avm. Patient had a fever and rash like symptoms that the physician suspected may be an allergy to nbca (either cyanoacrylate or ethiodized oil). Physician has not conclusively proven this at this time. The product did not expire.
Patient Sequence No: 1, Text Type: D, B5
[10294000]
(b)(4). The product will be returned for evaluation and testing. Additional information will be submitted within 30 days upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[10635924]
This (b)(6) male was treated with one kit of trufill nbca liquid embolic system ((b)(4)/lot unknown) for an arteriovenous malformation (avm). The patient had a fever and rash like symptoms that the physician suspected may be an allergy to nbca (either cyanoacrylate or ethiodized oil). The patient was discharged two days post procedure with a small rash on his feet and then was re-admitted the following day with a fever. The patient was then referred to an allergist for evaluation and a trufill kit for evaluation ((b)(4)/lot 268818) was supplied for evaluation under supervision of a physician. Additional follow-up information reported that the results of the allergy testing found that he was not allergic to nbca; they are not sure what caused the allergic reaction. The patient has since had follow-up treatment using nbca to obliterate the last of the avm. One month after this follow-up treatment there has been no sign of allergic reaction. The nbca remains implanted and the lot number is not available; therefore, the device history records review cannot be completed. The instructions for use outlines that allergic reaction is an adverse event which may be associated with embolization procedures (including those observed during the (b)(4) study) and may occur at any time during or after the procedure. The follow-up information reported negative allergy testing with an nbca test kit and follow-up treatment with nbca without any reaction. Additionally based on this, it was reported that it was determined that although the cause of the reported suspected allergic reaction is not known, it was not related to the nbca. Therefore, no corrective actions will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1058196-2012-00420 |
| MDR Report Key | 2840124 |
| Report Source | 05,07 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-11-02 |
| Date of Event | 2012-09-30 |
| Date Mfgr Received | 2013-03-05 |
| Date Added to Maude | 2012-11-20 |
| 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. MATTHEW KING |
| Manufacturer City | MIAMI LAKES FL 33014-280 |
| Manufacturer Postal | 33014-2802 |
| Manufacturer Phone | 88283106 |
| Manufacturer G1 | CORDIS CORPORATION |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014-28 |
| Manufacturer Postal Code | 33014-280 |
| Single Use | 3 |
| 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 | 2012-11-20 |
| Model Number | NA |
| Catalog Number | 631500 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-11-20 |