MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-06-22 for ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..
[461670]
Physician deployed the endosure sensor too high in the aaa sac. The physician could not reach the sensor to pull it into a sheath for removal. While manipulating the sheath, the sensor got caught on the fixation anchors of the gore stent graft, which prevented the stent graft from being positioned properly. The patient was converted to an open repair procedure, the sensor was removed and the pt was discharged without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2006-00002 |
| MDR Report Key | 728835 |
| Report Source | 07 |
| Date Received | 2006-06-22 |
| Date of Report | 2006-06-22 |
| Date of Event | 2006-05-24 |
| Date Mfgr Received | 2006-05-24 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-06-28 |
| 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 404 |
| Manufacturer City | ATLANTA GA 30308 |
| Manufacturer Country | US |
| Manufacturer Postal | 30308 |
| Manufacturer Phone | 4049206700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM |
| Generic Name | INTRASAC PRESSURE SENSOR/DELIVERY CATH |
| Product Code | NQH |
| Date Received | 2006-06-22 |
| Model Number | NA |
| Catalog Number | ADS-1001 |
| Lot Number | 01D015723 |
| ID Number | NA |
| Device Expiration Date | 2008-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 717118 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | * ATLANTA GA * US |
| Baseline Brand Name | ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM |
| Baseline Generic Name | INTRASAC PRESSURE SENSOR/DELIVERY CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | ADS-1001 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-06-22 |