MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-10-11 for manufactured by Sterilmed, Inc..
[3776872]
It was reported that at the end of the case an effusion was noticed on intracardiac echo. Because it was an epicardial ablation and epicardial access was available, fluid was withdrawn from the pericardial space and it was noticed that it was blood. The bleeding did not stop so an open thoracotomy was performed by ct surgery and cardiac perforation (tear of the coronary sinus) was confirmed. The perforation was closed and the patient was stabilized and under observation. Additional information has been requested. A follow-up report will be sent when additional information is received.
Patient Sequence No: 1, Text Type: D, B5
[11152963]
The device was not returned to the manufacturer as of the date of this report. A follow-up report will be sent after evaluation if the device is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2013-00214 |
| MDR Report Key | 3415510 |
| Report Source | 00 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-09-20 |
| Date of Event | 2013-08-22 |
| Date Mfgr Received | 2013-09-20 |
| Date Added to Maude | 2013-10-18 |
| 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 | TRICIA SCHRATER |
| Manufacturer Street | 11400 73RD AVE. NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7634883211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Product Code | OWQ |
| Date Received | 2013-10-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2013-10-11 |