MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-10-12 for EDOSURE 111 PRESSURE SENSOR/DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..
[21391616]
During insertion of the endosure aaa pressure sensor into a tortuous iliac artery, the delivery catheter tip detached. Removal of the tip was successfully performed. The case was completed and the pt was discharged from the hosp without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2006-00003 |
| MDR Report Key | 841559 |
| Report Source | 07 |
| Date Received | 2006-10-12 |
| Date of Report | 2006-09-25 |
| Date of Event | 2006-09-10 |
| Date Mfgr Received | 2006-09-10 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-04-28 |
| 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., 440 |
| 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 | EDOSURE 111 PRESSURE SENSOR/DELIVERY SYSTEM |
| Generic Name | INTRASAC PRESSURE SENSOR/DELIVERY CATHETER |
| Product Code | NQH |
| Date Received | 2006-10-12 |
| Model Number | NA |
| Catalog Number | ADS-1001 |
| Lot Number | OML60524-01 |
| ID Number | NA |
| Device Expiration Date | 2008-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 828820 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | * ATLANTA GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-12 |