MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-09 for 7FR SINGLE-USE ENDOMYOCARDIAL BIOPSY 5030 UNKNOWN manufactured by Atc Technologies.
[401545]
While performing right heart catheterization with biopsy, forceps failed. It appears the handle mechanism broke. It was replaced with similar device and procedure completed uneventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 584669 |
| MDR Report Key | 584669 |
| Date Received | 2005-03-09 |
| Date of Report | 2005-03-09 |
| Date of Event | 2005-01-21 |
| Report Date | 2005-03-09 |
| Date Reported to FDA | 2005-03-09 |
| Date Added to Maude | 2005-03-25 |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7FR SINGLE-USE ENDOMYOCARDIAL BIOPSY |
| Generic Name | 7FR SINGLE-USE ENDOMYOCARDIAL BIOPSY |
| Product Code | DWZ |
| Date Received | 2005-03-09 |
| Model Number | 5030 |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 574501 |
| Manufacturer | ATC TECHNOLOGIES |
| Manufacturer Address | 80 CUMMINGS PARK WOBURN MA 01801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-09 |