MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-08 for ENDOSURE S2 PRESSURE MEASUREMENT SYSTEM S2-2080 manufactured by Cardiomems, Inc..
[1228147]
Sensor delivered without issue. Sensor was unable to be release from the delivery system. Sensor was removed from the patient with some blood loss. No additional sensor was placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2009-00002 |
| MDR Report Key | 1466095 |
| Report Source | 07 |
| Date Received | 2009-06-08 |
| Date of Report | 2009-05-29 |
| Date of Event | 2009-05-14 |
| Date Mfgr Received | 2009-05-14 |
| Device Manufacturer Date | 2009-03-02 |
| Date Added to Maude | 2010-02-04 |
| 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 Street | 387 TECHNOLOGY CIRCLE, NW SUITE 500 |
| Manufacturer City | ATLANTA GA 30313 |
| Manufacturer Country | US |
| Manufacturer Postal | 30313 |
| Manufacturer Phone | 6786512300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSURE S2 PRESSURE MEASUREMENT SYSTEM |
| Generic Name | INTRAVASCULAR PRESSURE SENSOR |
| Product Code | NQH |
| Date Received | 2009-06-08 |
| Returned To Mfg | 2009-05-18 |
| Catalog Number | S2-2080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30313 US 30313 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-06-08 |