MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-12-01 for FLOSEAL MATRIX HEMOSTATIC SEALANT FR0002 manufactured by Baxter Healthcare Corporation.
[571549]
Dr's patient had a total knee arthroplasty in 2006. Per pa for dr, patient had a tia (transient ischemic attack). Autotransfusion drain placed. Patient has a history of tias. Floseal applied with tourniquet up. Additional information received 07-nov-06: pa does not believe tia to be caused by floseal, due to patient's history.
Patient Sequence No: 1, Text Type: D, B5
[7806838]
Baxter medical director assessment: november 11, 2006: based on the narrative we cannot rule out that floseal and its mishandling have contributed to the adverse event. A transient ischemic attack (tia) is caused by an interruption of blood flow to brain cells. If the symptoms resolve completely in less than 24 hours, this is called a tia or "mini stroke. " a brief interruption to the blood flow can cause a decrease in brain function (neurological deficit). The following can cause the loss of blood circulation to the brain: narrowing of a blood vessel. Blood clotting within an artery of the brain. Blood clot traveling to the brain from somewhere else in the body (e. G. , heart). A blood disease, cancer, and others. Inflammation of blood vessels. Injury to blood vessels. In a tia, the blood supply is only temporarily blocked. For example, a blood clot may dissolve and allow blood to flow normally again. Given the patient's history of previous tias, the event has been probably caused by alternative causes, other than floseal. Nevertheless, the application of floseal in a dry area (tourniquet on) and in the presence of the autotransfusion drain places, are factors that may increase the risk of intravascular application of floseal. Besides of that, in order to work, floseal needs flowing blood (fibrinogen) to react and stop eventual bleeding. The floseal ifu is adequately addressing all these relevant safety and application aspects referred in this case. The instruction of the reporter's pa through medical affairs was adequate. Still, the relevant person to be retrained is the surgeon, md biosurgery. Retraining/re-education description: baxter rn, discussed with surgeon pa, the precaution of using autologous blood salvage circuits with floseal. (patient had an autotransfusion drain placed). Also discussed the need for the tourniquet to be down, as floseal requires active bleeding and should not be applied to a clamped vessel, which a tourniquet would stimulate. Also discussed that floseal should not be compressed into blood vessels. After the conversation, based upon discussion (per phone) that baxter rn, baxter sales, had with pa earlier today, he said he had no further questions. Additional retraining/re-education is needed with the surgeon who performed the prcoedure. A session has been scheduled with dr the week of december 11th. A follow-up report will be sent upon its completion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954761-2006-00015 |
| MDR Report Key | 789848 |
| Report Source | 05 |
| Date Received | 2006-12-01 |
| Date of Report | 2006-12-01 |
| Date of Event | 2006-11-02 |
| Date Mfgr Received | 2006-11-03 |
| Date Added to Maude | 2006-12-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOSHUA LEACH, SPECIALIST |
| Manufacturer Street | ONE BAXTER WAY |
| Manufacturer City | WESTLAKE VILLAGE CA 91362 |
| Manufacturer Country | US |
| Manufacturer Postal | 91362 |
| Manufacturer Phone | 8053723250 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOSEAL MATRIX HEMOSTATIC SEALANT |
| Generic Name | HEMOSTATIC SEALANT |
| Product Code | EBC |
| Date Received | 2006-12-01 |
| Model Number | FR0002 |
| Catalog Number | FR0002 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 777524 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 34175 ARDENWOOD BLVD. FREMONT CA 94555 US |
| Baseline Brand Name | FLOSEAL MATRIX HEMOSTATIC SEALANT |
| Baseline Generic Name | DEVICES |
| Baseline Model No | FR0002 |
| Baseline Catalog No | FR0002 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-12-01 |