MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-03-12 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM * ADS-1001 manufactured by Cardiomems.
[20618682]
Patient had tortuous iliacs bilaterally. When sensor delivery system was inserted, physician met resistance. Upon removal, it was found that the dilator tip detached from the catheter body. A snare was used to retrieve the tip. Patient did not suffer any subsequent injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00002 |
| MDR Report Key | 827939 |
| Report Source | 07 |
| Date Received | 2007-03-12 |
| Date of Report | 2007-03-12 |
| Date of Event | 2007-01-10 |
| Date Mfgr Received | 2007-01-10 |
| Date Added to Maude | 2007-03-16 |
| 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., N.W. STE., 440 |
| Manufacturer City | ATLANTA GA 30308 |
| Manufacturer Country | US |
| Manufacturer Postal | 30308 |
| Manufacturer Phone | 4049206712 |
| 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 | 2007-03-12 |
| Returned To Mfg | 2007-02-09 |
| Model Number | * |
| Catalog Number | ADS-1001 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 815344 |
| Manufacturer | CARDIOMEMS |
| Manufacturer Address | * ATLANTA GA * US |
| Baseline Brand Name | ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM |
| Baseline Generic Name | INTRASAC PRESSURE SENSOR/DELIVERY CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | ADS-1001 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-12 |