MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-13 for ACQMAP? 3D IMAGING AND MAPPING CATHETER 900003 manufactured by Acutus Medical, Inc..
[175074412]
It is not known what caused the pericardial effusion. It is highly unlikely that the pericardial effusion was caused by the acqmap catheter. Specifically, as stated by the acutus account manager in the event description, the acqmap catheter used in the case was not returned for investigation; the catheter was disposed of by the medical facility staff. There were several procedure related opportunities that may have contributed to or caused the event. Although a single transseptal puncture was used to access the left atrium, the procedure itself is technically demanding and carries the risk of severe complications including pericardial effusion. The acutus account manager talked to the physician after the reported adverse event and no statement by physician indicating the acqmap catheter was connected to the event. Therefore, since it cannot be determined what if any the acutus system may have played role in this event although it is likely procedure-related, and we believe reporting this event conservatively based on the available information.
Patient Sequence No: 1, Text Type: N, H10
[175074413]
On 11 dec 2019 it was reported that standard procedural setup including standard transseptal puncture and pulmonary vein angiography were performed. The ultrasound anatomy reconstruction and atrial fibrillation baseline was recorded by the acutus acqmap system. Several attempts at direct current cardioversion (dccv) to sinus rhythm were unsuccessful. The physician then decided to ablate the anteroseptal line and posterior line. Ablation was conducted from the middle vein line to the left inferior pulmonary vein. An additional dccv attempt was unsuccessful. Extensive ablation was performed from the anterior line to the base of the left atrial appendage and the posterior line. An additional dccv attempt was unsuccessful. The ablation catheter was moved into the agilis sheath and both catheters were moved into the right atrium (ra). Coronary sinus angiography was performed and ablation in the coronary sinus was completed. An anatomy of the ra was reconstructed using the acutus acqmap system and a map was created. The acqmap catheter was retracted into the sheath and remained in the ra. At this time the physician mentioned that the patient's blood pressure was decreasing. An ultrasound echocardiogram confirmed a pericardial effusion. A pericardial puncture was initiated using standard practices wherein the pericardium was punctured via long needle below sternum. A wire was inserted to ensure no puncture of the epicardium and a pigtail catheter was used to remove blood from the paracardial sac. Patient was administered protamine to initiate blood clotting. The patient was stabilized, and the procedure was aborted. The patient left the ep lab in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012120746-2020-00001 |
| MDR Report Key | 9582957 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2019-07-31 |
| Date Added to Maude | 2020-01-13 |
| 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 | MS. KAREN KINCADE |
| Manufacturer Street | 2210 FARADAY AVENUE SUITE 100 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 4422326123 |
| Manufacturer G1 | ACUTUS MEDICAL, INC. |
| Manufacturer Street | 2210 FARADAY AVENUE SUITE 100 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACQMAP? 3D IMAGING AND MAPPING CATHETER |
| Generic Name | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY |
| Product Code | MTD |
| Date Received | 2020-01-13 |
| Model Number | 900003 |
| Catalog Number | 900003 |
| Lot Number | 100287 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACUTUS MEDICAL, INC. |
| Manufacturer Address | 2210 FARADAY AVENUE SUITE 100 CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-01-13 |