MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-06-14 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..
[669373]
The delivery system was removed from the patient due to severe kinking of the tether by the physician. After removing the delivery system, it was noted that the sensor had been released and was left in the iliac artery. The sensor was removed which created a small tear in the iliac. The tear as repaired and the patient was discharged with no issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00006 |
| MDR Report Key | 865886 |
| Report Source | 07 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-06-08 |
| Date of Event | 2007-05-18 |
| Date Mfgr Received | 2007-05-20 |
| Date Added to Maude | 2007-06-27 |
| 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 | 75 FIFTH ST., NW SUITE 440 |
| Manufacturer City | ATLANTA GA 30308 |
| Manufacturer Country | US |
| Manufacturer Postal | 30308 |
| Manufacturer Phone | 4049206719 |
| 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 | 2007-06-14 |
| Catalog Number | ADS-1001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 848754 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30308 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-06-14 |