MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-20 for ENDOMYOCARDIAL BIOPSY FORCEP manufactured by Argon Medical Devices, Inc..
[106023906]
Patient Sequence No: 1, Text Type: N, H10
[106023907]
Reportedly, during a myocardial biopsy when inserting the argon biopsy forcep into the sheath and while squeezing the handle to get a piece of the right ventricle, the spring in the handle snapped leaving the forceps in the open position. An x-ray was used to help remove the forceps, given the forcep was stuck in an open position. Reportedly, all the pieces were recovered and the forceps were able to be removed. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7446217 |
| MDR Report Key | 7446217 |
| Date Received | 2018-04-20 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-03-28 |
| Report Date | 2018-04-16 |
| Date Reported to FDA | 2018-04-16 |
| Date Reported to Mfgr | 2018-04-16 |
| Date Added to Maude | 2018-04-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2018-04-20 |
| Returned To Mfg | 2018-03-28 |
| ID Number | FORCEP BIOPSY 2.4MM X 50CM |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2018-04-20 |