MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-15 for NBCA LIQUID EMBOLIC SYSTEM 2 631500 manufactured by Codman And Shurtleff, Inc.
[92909481]
(b)(4). The device was returned for analysis; however, the analysis has not yet been completed. Additional information will be submitted within 30 days of receipt. This is 1 of 4 mdrs submitted for this complaint with associated report numbers of 1226348-2017-00194, 1226348-2017-00193, 1226348-2017-00192 and 1226348-2017-00191.
Patient Sequence No: 1, Text Type: N, H10
[92909482]
As reported by a physician, when injecting glue with tantalum and aprox 1/2 cc to 1cc of oil, the glue was not visible as injecting under fluro. Product included trufill nbca 1 gram kit (631500/ ha2573 x 2, 631500/ hf2890 x 1, and unknown catalog/lot x 1). The embolization procedure was for treatment of vein of galin on a (b)(6) infant. The physician, who has been successfully been using nbca glue for many years, added the entire packet of tantalum powder with oil (approx. ? Cc to 1cc of oil) to the nbca glue in a glass beaker. The radiopacity of the mixture was not confirmed via flouro prior to injection by comparing the glue to a similar syringe containing contrast as instructed in the ifu. Four separate injections were used and they appeared very faint via flouro, and in one case, the tantalum appeared to be beaded. It was reported that the oil had been protected from light and the mixture was prepared as per the instructions for use (ifu). Fortunately, the patient was successfully treated with no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2017-00194 |
| MDR Report Key | 7035073 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-15 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2017-05-31 |
| Date Added to Maude | 2017-11-15 |
| 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 | JOAQUIN KURZ |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 9497899383 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NBCA LIQUID EMBOLIC SYSTEM 2 |
| Generic Name | TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS |
| Product Code | KGG |
| Date Received | 2017-11-15 |
| Returned To Mfg | 2017-11-10 |
| Model Number | NA |
| Catalog Number | 631500 |
| Lot Number | HA2573 |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF, INC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-15 |