MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-03-30 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM * ADS-1001 manufactured by Cardiomems, Inc..
[606062]
The iliac was very diseased and tortuous. The physician had to balloon to place an 18f sheath. The sensor delivery system was then introduced. While retracting the delivery system some resistance was met. After the delivery system was removed, it was noted that the dilator tip was missing. The dilator tip, although on the guidewire, was unable to be recaptured. The dilator tip was left in the excluded aneurysm sac parallel to the stent graft. The patient was released from the hospital with no further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00004 |
| MDR Report Key | 836827 |
| Report Source | 07 |
| Date Received | 2007-03-30 |
| Date of Report | 2007-03-30 |
| Date of Event | 2007-03-14 |
| Date Mfgr Received | 2007-03-14 |
| Date Added to Maude | 2007-04-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 75 FIFTH ST., NW STE., 440 |
| Manufacturer City | ATLANTA GA 30308 |
| Manufacturer Country | US |
| Manufacturer Postal | 30308 |
| Manufacturer Phone | 4049206719 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2007-03-30 |
| Model Number | * |
| Catalog Number | ADS-1001 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 824123 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | * ATLANTA GA 30308 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-30 |