MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-08-15 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM * S2-2080 manufactured by Cardiomems, Inc..
[16705512]
Patient has heavily calcified iliac arteries. Sensor was introduced through a 14f sheath via stiff guidewire. A pigtail catheter was introduced beside the sensor delivery system. There was visible blood coming from the sheath and there were attempts made to contain and stop the blood loss. Bleeding continued throughout the procedure and patient's blood pressure dropped. The pt had to be put on cell saver and ultimately was given blood. The sensor delivery was still successful and patient was stable at the end of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00012 |
| MDR Report Key | 903482 |
| Report Source | 07 |
| Date Received | 2007-08-15 |
| Date of Report | 2007-08-15 |
| Date of Event | 2007-08-09 |
| Date Mfgr Received | 2007-08-09 |
| Date Added to Maude | 2007-08-29 |
| 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 | 3 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2007-08-15 |
| Model Number | * |
| Catalog Number | S2-2080 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 878661 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | * ATLANTA GA 30313 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-15 |