MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-30 for ENCLOSURE SENSOR * ADS-1001 manufactured by Cardio Mem's.
[606421]
During a routine endovascular abdominal aortic aneurysm repair on 03/14/07 at the time of deployment of the cardiomem pressure sensor, the sensor came loose and deployed within the excluded aneurysm sac. Multiple attempts were made to retrieve the sensor without success. Length of tip left in pt was approximately 2 - 2. 5 inches. Patient will be followed closely by md.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042461 |
| MDR Report Key | 835156 |
| Date Received | 2007-03-30 |
| Date of Report | 2007-03-30 |
| Date of Event | 2007-03-14 |
| Date Added to Maude | 2007-04-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENCLOSURE SENSOR |
| Generic Name | SAME |
| Product Code | NQH |
| Date Received | 2007-03-30 |
| Returned To Mfg | 2007-03-14 |
| Model Number | * |
| Catalog Number | ADS-1001 |
| Lot Number | 09D032501 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 822480 |
| Manufacturer | CARDIO MEM'S |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-30 |