MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-11-01 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080 manufactured by Cardiomems, Inc..
[711927]
The sensor and delivery system were placed through a conduit and into a thoracic aneurysm (off-label use). There was bleeding during the placement of the sensor. A 20f sheath for the endograft was then placed beside the sensor delivery system. There was add'l bleeding while the sensor was on the delivery system next to this 20f sheath. The patient required a unit of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00017 |
| MDR Report Key | 937404 |
| Report Source | 07 |
| Date Received | 2007-11-01 |
| Date of Report | 2007-10-19 |
| Date of Event | 2007-10-17 |
| Date Mfgr Received | 2007-10-18 |
| Date Added to Maude | 2007-11-13 |
| 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 | 2007-11-01 |
| Catalog Number | S2-2080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 912049 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30313 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-01 |