MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-01-27 for REFLEXION CATHETER UNK manufactured by St. Jude Medical, Inc. (af-minnetonka).
[21874746]
Related manufacturer reference 3005188751-2014-00007, 3005188751-2014-00008, 3005188751-2014-00009. After the completion of a cardiac ablation procedure, a pericardial effusion occurred. Once all devices had been removed, the patient complained of discomfort and became hypotensive. A transthoracic echocardiogram revealed a pericardial effusion. A pericardiocentesis was performed to stabilize the patient. There were no performance issues with any sjm device.
Patient Sequence No: 1, Text Type: D, B5
[21914049]
Method: the results of the investigation are inconclusive since the device was not returned for analysis. A review of the device history record was not possible since the lot number was unavailable. Based on the info rec'd, the cause of the reported pericardial effusion could not be conclusively determined. Per the ifu, cardiac perforation is a known inherent risk during the use of this device in the heart.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005188751-2014-00010 |
| MDR Report Key | 3629038 |
| Report Source | 01,05,07 |
| Date Received | 2014-01-27 |
| Date of Report | 2014-01-10 |
| Date of Event | 2014-01-10 |
| Date Mfgr Received | 2014-01-10 |
| Date Added to Maude | 2014-02-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE JOHNSON, RN |
| Manufacturer Street | 177 EAST COUNTRY ROAD B |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517564071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLEXION CATHETER |
| Product Code | HCC |
| Date Received | 2014-01-27 |
| Model Number | UNK |
| 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. (AF-MINNETONKA) |
| Manufacturer Address | MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-27 |