MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-12-03 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080 manufactured by Cardiomems, Inc..
[16171981]
Patient had very tight calcified iliac arteries. The sensor was inserted and would not advance completely through the sheath. When trying to advance for a third time, the sheath was pulled back and the catheter was broken, leaving the sensor and distal end of the catheter in the artery. A right common iliac cut down was performed to remove the sensor and distal end of the catheter. Another sensor was not attempted. Endarterectomies were performed on both sides to place the stent graft. The overall procedure was successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00013 |
| MDR Report Key | 1301718 |
| Report Source | 07 |
| Date Received | 2008-12-03 |
| Date of Report | 2007-08-23 |
| Date of Event | 2007-08-13 |
| Date Mfgr Received | 2007-08-15 |
| Date Added to Maude | 2009-11-09 |
| 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 | 6786512323 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOMEMS ENDOSURE DELIVERY SYSTEM |
| Generic Name | INTRAVASCULAR PRESSURE SENSOR |
| Product Code | NQH |
| Date Received | 2008-12-03 |
| Returned To Mfg | 2007-08-15 |
| 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 | 2008-12-03 |