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 2018-01-18 for REFLEXION? SPIRAL EP CATHETER manufactured by St. Jude Medical, Inc..
[97650937]
A pericardial effusion was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Review of the device history record was not possible as the lot number is unknown. Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined. Per the ifu, cardiac perforation is a known risk during the use of this device.
Patient Sequence No: 1, Text Type: N, H10
[97650938]
Manufacturing related reference: 9680001-2018-00003, 2182269-2018-00011. During a pulmonary vein isolation procedure, a pericardial effusion occurred. Following several lesions, the patient became hypotensive and an ice catheter confirmed a posterior pericardial effusion. The patient was observed in the lab for 30 minutes, pressure resolved and the effusion improved. No intervention was necessary and the patient left the lab in stable condition. There were no performance issues with any abbott devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182269-2018-00012 |
| MDR Report Key | 7203052 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-18 |
| Date of Report | 2018-01-18 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-01-04 |
| Date Added to Maude | 2018-01-18 |
| 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 | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517564470 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. |
| Manufacturer Street | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 55345 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55345 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLEXION? SPIRAL EP CATHETER |
| Generic Name | ELECTROPHYSIOLOGY (STEERABLE) |
| Product Code | IKD |
| Date Received | 2018-01-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 14901 DEVEAU PLACE MINNETONKA MN 55345 US 55345 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-18 |