MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-26 for ENDOMYOCARDIAL BIOPSY FORCEP 190030 manufactured by Argon Medical Devices, Inc..
[103416735]
Patient Sequence No: 1, Text Type: N, H10
[103416736]
Reportedly, on three separate occasions and three separate patients, while obtaining a biopsy from myocardial tissue and attempting to pull the biopsy forcep out of the body, the forceps would not close. Reportedly, in one of the patients the sheath had to be removed and replaced in order to remove the forceps safely. Reportedly, there was no harm to any of the patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7369302 |
| MDR Report Key | 7369302 |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-22 |
| Report Date | 2018-03-22 |
| Date Reported to FDA | 2018-03-22 |
| Date Reported to Mfgr | 2018-03-22 |
| Date Added to Maude | 2018-03-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOMYOCARDIAL BIOPSY FORCEP |
| Generic Name | DEVICE, BIOPSY, ENDOMYOCARDIAL |
| Product Code | DWZ |
| Date Received | 2018-03-26 |
| Model Number | 190030 |
| Catalog Number | 190030 |
| Lot Number | 3974116 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | 1445 FLAT CREEK RD. ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-26 |