MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-12 for ENDOMYOCARDIAL BIOPSY FORCEP 190051 manufactured by Argon Medical Devices, Inc..
[75005117]
Patient Sequence No: 1, Text Type: N, H10
[75005118]
Patient admitted for cardiac biopsy to rule out amyloidosis. Upon attempt to retrieve tissue sample the endomyocardial biopsy forcep became stuck in the superior vena cava (svc) right atrial junction and failed to open or release despite multiple attempts to open up. Patient was subsequently admitted emergently to the operating room where a sternotomy and small venotomy was completed to remove the biopsy forcep. Manufacturer response for endomyocardia biopsy forcep, endomyocardial biopsy forcep (per site reporter): unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6562757 |
| MDR Report Key | 6562757 |
| Date Received | 2017-05-12 |
| Date of Report | 2017-05-03 |
| Date of Event | 2017-04-11 |
| Report Date | 2017-04-30 |
| Date Reported to FDA | 2017-04-30 |
| Date Reported to Mfgr | 2017-04-30 |
| Date Added to Maude | 2017-05-12 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 2017-05-12 |
| Returned To Mfg | 2017-04-12 |
| Model Number | 190051 |
| Catalog Number | 190051 |
| Lot Number | G14888 |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-05-12 |