MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-07-23 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..
[17067421]
The patient had tortuous iliacs and severe calcification at the bifurcation. The first delivery system was kinked before entering the body by the scrub tech. The second device was delivered with no problems. When the delivery system was removed from the body, it was noted that the nose cone tip had detached. The nose cone was retrieved with a snare and pulled into a sheath. The case ended with good results and no additional problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00009 |
| MDR Report Key | 886246 |
| Report Source | 07 |
| Date Received | 2007-07-23 |
| Date of Report | 2007-07-23 |
| Date of Event | 2007-06-12 |
| Date Mfgr Received | 2007-06-12 |
| Date Added to Maude | 2007-08-27 |
| 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 STREET 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 | 2007-07-23 |
| 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 | 877232 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30308 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-07-23 |