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 2019-01-04 for TRUFILL N-BCA-1 GRAM KIT 631500 manufactured by Codman And Shurtleff, Inc.
[132199091]
Product complaint # (b)(4). Information regarding patient weight, height, medical history, race, and ethnicity was not reported. Lot: the reported product lot number (hn1042) is the glue sub-assembly of the trufill n-bca-1 gram kit. The lot number of the kit that was used in the case is currently unknown. The potential lot numbers are hr1780 and hp6250. The manufacturing and quality records will be reviewed for both lots as applicable per our internal procedure. These records will comprise our lots/batches history records, which were created during the manufacturing of the device. The product is not available for evaluation and testing. Additional information will be submitted within 30 days of receipt. The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Patient Sequence No: 1, Text Type: N, H10
[132199092]
As reported by a healthcare professional, a (b)(6) year-old male patient with an unreported medical history underwent a left middle cerebral artery embolization using nbca glue (631500/hr1780 or hp6250) and 8 hours later developed a subsequent ischemic stroke from the embolic material. The pathology report confirmed that the embolic material captured in thrombectomy was black pigmented and suggestive of nbca. It was reported that the product was discarded. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2019-00815 |
| MDR Report Key | 8219405 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-04 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2018-01-04 |
| Date Added to Maude | 2019-01-04 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 9497898687 |
| Manufacturer G1 | CODMAN AND SHURTLEFF, INC |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUFILL N-BCA-1 GRAM KIT |
| Generic Name | TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS |
| Product Code | KGG |
| Date Received | 2019-01-04 |
| Catalog Number | 631500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF, INC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2019-01-04 |