MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-20 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM * ADS-1001 manufactured by Cardiomems, Inc..
[628527]
This was a percutaneous case to treat two abdominal aortic aneurysms that were in an hour glass formation. The plan was to place the sensor in the lower aneurysm just above the bifurcation. After access was gained, a heavily calcified iliac, which was not visible under fluoroscopy, caused difficult access and bent the protective capsule section of the delivery system. This bend caused the tether to kink while attempting to advance forward. The sensor did advance up to the lower aneurysm sac. Upon removal of the delivery system, the bend in the delivery system capsule caused the sensor and tether to be pulled back into the iliac and then femoral artery. The physician then attempted to pull the sensor out through the percutaneous access sight and accidentally released the sensor in the femoral artery. A cutdown was performed and the sensor was retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00005 |
| MDR Report Key | 847138 |
| Report Source | 07 |
| Date Received | 2007-04-20 |
| Date of Report | 2007-04-20 |
| Date of Event | 2007-04-09 |
| Date Mfgr Received | 2007-04-14 |
| Date Added to Maude | 2007-05-15 |
| 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 | 75 FIFTH ST., NW STE. 440 |
| Manufacturer City | ATLANTA GA 30308 |
| Manufacturer Country | US |
| Manufacturer Postal | 30308 |
| Manufacturer Phone | 4049206719 |
| 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 | 2007-04-20 |
| Model Number | * |
| Catalog Number | ADS-1001 |
| 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 | 834186 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | * ATLANTA GA 30308 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-20 |