MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F MX6721 manufactured by Cordis Santa Clara.
[186844331]
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[186844332]
During the use of a 6f/7f mynx grip vascular closure device (vcd), the shuttle did not go down. There was no reported patient injury. The device is expected to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004939290-2020-01689 |
| MDR Report Key | 9903184 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2018-12-10 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARLA CASTRO |
| Manufacturer Street | 5452 BETSY ROSS DRIVE |
| Manufacturer City | SANTA CLARA CA 95054 |
| Manufacturer Country | US |
| Manufacturer Postal | 95054 |
| Manufacturer Phone | 7863138372 |
| Manufacturer G1 | CORDIS SANTA CLARA |
| Manufacturer Street | 5452 BETSY ROSS DRIVE |
| Manufacturer City | SANTA CLARA CA 95054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F |
| Generic Name | DEVICE, HEMOSTASIS, VASCULAR |
| Product Code | MGB |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-20 |
| Model Number | MX6721 |
| Catalog Number | MX6721 |
| Lot Number | F1834002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS SANTA CLARA |
| Manufacturer Address | 5452 BETSY ROSS DRIVE SANTA CLARA CA 95054 US 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |