MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-03-29 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM * ADS-1001 manufactured by Cardiomems, Inc..
[592977]
Pt had very tortuous iliacs. Sensor delivery system was introduced and did not meet any resistance but the delivery system sheath kinked causing the guidewire not to be able to move. The entire system was removed and upon inspection the delivery system looked kinked. An inspection with fluoroscopy was performed and it was determined that the iliac was torn so that repair was needed. Due to tortuosity, the pt required an open repair. The pt was discharged without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00003 |
| MDR Report Key | 833779 |
| Report Source | 07 |
| Date Received | 2007-03-29 |
| Date of Report | 2007-03-29 |
| Date of Event | 2007-03-19 |
| Date Mfgr Received | 2007-03-19 |
| Date Added to Maude | 2007-04-04 |
| 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 | 2007-03-29 |
| 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 | 821099 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | * ATLANTA GA 30308 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-29 |