MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-01-02 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..
[15700987]
The sensor/delivery system was inserted through the tortuous right iliac. The delivery system met resistance. After the system would not advance any further, it was removed. The tip of the delivery system was detached and remained on the guidewire. The vessel was cut down further up the iliac and the tip was retrieved. Another attempt to insert a sensor/delivery system was unsuccessful. No sensor was placed. The patient was discharged without any further issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00018 |
| MDR Report Key | 973558 |
| Report Source | 07 |
| Date Received | 2008-01-02 |
| Date of Report | 2007-12-11 |
| Date of Event | 2007-11-26 |
| Date Mfgr Received | 2007-12-07 |
| Date Added to Maude | 2008-01-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 387 TECHNOLOGY CIRCLE, NW SUITE 500 |
| Manufacturer City | ATLANTA GA 30313 |
| Manufacturer Country | US |
| Manufacturer Postal | 30313 |
| Manufacturer Phone | 6786512300 |
| 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 | 2008-01-02 |
| Catalog Number | ADS-1001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 942798 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30313 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-02 |