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 2020-03-20 for HEARTLIGHT 18-2531-N250 manufactured by Cardiofocus.
[186760746]
No device deficiency reported. Phrenic nerve injury leading to diaphragmmatic paralysis is a known potential adverse event for catheter ablation procedures disclosed in product labeling.
Patient Sequence No: 1, Text Type: N, H10
[186760747]
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, phrenic nerve paralysis was confirmed while ablating the right superior pulmonary vein (rspv). The procedure was completed. Phrenic nerve pacing at the end of the procedure showed no phrenic nerve capture. On the day after the procedure it was reported the patient had a small degree of breathing difficulty with diaphragmatic paralysis visually confirmed. The patient was released following standard hospital protocol. There was no prolongation of hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225698-2020-00010 |
| MDR Report Key | 9862800 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-09-26 |
| Date Added to Maude | 2020-03-20 |
| 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. IAN CHRISTIANSON |
| Manufacturer Street | 500 NICKERSON RD. SUITE 500-200 |
| Manufacturer City | MARLBORO, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 6587231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTLIGHT |
| Generic Name | HEARTLIGHT CATHETER |
| Product Code | OAE |
| Date Received | 2020-03-20 |
| Model Number | 18-2531-N250 |
| Catalog Number | 18-2531-N250 |
| Lot Number | 11787-002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOFOCUS |
| Manufacturer Address | 500 NICKERSON RD. SUITE 500-200 MARLBORO, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |