MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-09 for CERES C22113 manufactured by Ceres Interventional, Inc..
[1509961]
Bioptome catheter forceps failed to obtain an endomyocardial biopsy sample. A second bioptome catheter was used which worked perfectly. The patient had no complications during this procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1700212 |
| MDR Report Key | 1700212 |
| Date Received | 2010-05-09 |
| Date of Report | 2010-05-09 |
| Date of Event | 2010-02-23 |
| Report Date | 2010-05-09 |
| Date Reported to FDA | 2010-05-09 |
| Date Added to Maude | 2010-05-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERES |
| Generic Name | ENDOMYOCARDIAL BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 2010-05-09 |
| Returned To Mfg | 2010-03-19 |
| Model Number | NA |
| Catalog Number | C22113 |
| Lot Number | 01417006 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERES INTERVENTIONAL, INC. |
| Manufacturer Address | 4665 SWEETWATER BLVD. SUITE 104 SUGAR LAND TX 77479 US 77479 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-09 |