MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-03-17 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080 manufactured by Cardiomems, Inc..
[837755]
The sensor was delivered to the aaa with no issues. Upon delivery of the contralateral limb of the stent graft, the limb was unable to be positioned properly because the guidewire for the limb was wrapped around the sensor delivery system. Both the sensor delivery system and the contralateral limb were removed from the pt. The limb was reintroduced without issues. The sensor was not placed in the pt. The case was completed without any further issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2008-00001 |
| MDR Report Key | 1016098 |
| Report Source | 07 |
| Date Received | 2008-03-17 |
| Date of Report | 2008-03-17 |
| Date of Event | 2008-03-11 |
| Date Mfgr Received | 2008-03-13 |
| Date Added to Maude | 2008-06-18 |
| 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 | 2008-03-17 |
| Catalog Number | S2-2080 |
| 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 | 1021984 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30313 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-03-17 |