MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-05-10 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080 manufactured by Cardiomems, Inc..
[841175]
The physician had difficulty advancing the delivery system with sensor into aneurysm sac. The physician elected to remove the delivery system with sensor via a 14fr sheath. During removal, the sensor was untethered from the delivery system and remained inside the 14fr sheath. During sheath exchange, the sensor remained in the iliac artery. A snare was used to try to retrieve the sensor but was unsuccessful. The sensor was then pushed proximal to the aneurysm sac. Additional attempts were made to retrieve the sensor with the snare but these were unsuccessful. A lateral image of the sensor was taken which confirmed that the sensor was located in the aneurysm sac. The sensor remained in the aneurysm sac and the procedure continued without any additional issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2008-00002 |
| MDR Report Key | 1041380 |
| Report Source | 07 |
| Date Received | 2008-05-10 |
| Date of Report | 2008-04-24 |
| Date of Event | 2008-04-17 |
| Date Mfgr Received | 2008-04-22 |
| Date Added to Maude | 2008-07-11 |
| 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 Contact | GRACE POWERS |
| Manufacturer Street | 387 TECHNOLOGY CIRCLE, NW SUITE 500 |
| Manufacturer City | ATLANTA GA 303132424 |
| Manufacturer Country | US |
| Manufacturer Postal | 303132424 |
| Manufacturer Phone | 6786512323 |
| 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 | 2008-05-10 |
| Catalog Number | S2-2080 |
| Operator | OTHER |
| 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 | 1016784 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | 387 TECHNOLOGY CIRCLE, NW SUITE 500 ATLANTA GA 303132424 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-10 |