MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-02 for COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM 001-700-001MI manufactured by Atricure, Inc..
[140615008]
(b)(4) the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the epi-sense device was not reported or able to be subsequently ascertained. The complaint could not be confirmed. There was no reported device malfunction or procedural complications.
Patient Sequence No: 1, Text Type: N, H10
[140615009]
It was reported that on (b)(6) 2018, a (b)(6)-year-old male patient underwent an on-pump 2 vessel cabg/epicardial ablation with cobra fusion. The patient was heparinized intra-operatively with an act of >350 seconds. Patient? S medical history included 3 vessel coronary disease, levf of 40-50%, chronic renal insufficiency, copd, af, hypertonia and hyperlipidemia. There was no reported procedural complications and no device malfunctions. Post-op, during the weaning process it was noticed that there was lack of movement of patient? S left half of the body; ct confirmed anterior infarction. The patient was moved to the stroke unit and moved to neurological rehabilitation clinic on (b)(6) 2018 with mild to moderate motor deficit and dysarthria. This event is a procedure related complication, there was no reported device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00015 |
| MDR Report Key | 8473210 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-02 |
| Date of Report | 2019-04-05 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2019-03-06 |
| Date Added to Maude | 2019-04-02 |
| 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. JOHN EHLERT |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45212 |
| Manufacturer Country | US |
| Manufacturer Postal | 45212 |
| Manufacturer Phone | 5137554563 |
| Manufacturer G1 | ATRICURE, INC. |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM |
| Generic Name | COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM |
| Product Code | OCL |
| Date Received | 2019-04-02 |
| Model Number | 001-700-001MI |
| Catalog Number | 001-700-001MI |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-04-02 |