MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-11-28 for ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM * manufactured by Cardiomems, Inc..
[543071]
The guidewire was inadvertantly removed during sensor delivery, causing movement of the delivery system without guidewire support. When the delivery catheter was removed, the physician noted that the nose cone was detached. The nose cone was removed and a second device was inserted without difficulty. The pt was discharged without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2006-00005 |
| MDR Report Key | 791829 |
| Report Source | 07 |
| Date Received | 2006-11-28 |
| Date of Report | 2006-11-28 |
| Date of Event | 2006-11-02 |
| Date Mfgr Received | 2006-11-02 |
| Date Added to Maude | 2006-12-11 |
| 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 | ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM |
| Generic Name | INTRASAC PRESSURE SENSOR/DELIVERY CATH |
| Product Code | NQH |
| Date Received | 2006-11-28 |
| Returned To Mfg | 2006-11-27 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 779468 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | * ATLANTA GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-11-28 |