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 5F MX5021 manufactured by Cordis Santa Clara.
[186844426]
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. A non-sterile mynxgrip vascular closure device 5f involved in the reported complaint was returned for investigation. Visual inspection of the returned device showed that the shuttle cartridge was engaged to the handle and the sealant and advancer tube remained inside the shuttle cartridge. The procedural sheath was not returned with the device for investigation. No other visual damages or anomalies were observed. Functional testing was performed on the received device. The sheath involved in the event was not returned; therefore, an applicable lab sample was used for performing the insertion (per the mynx instructions for use) on the returned device. No resistance was felt during investigation when the device being inserted and withdrawn. Visual inspection at high magnification showed the catheter? S distal tip was slightly bent and free of damage. Additional information is pending and will be submitted within 30 days upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[186844427]
As reported, the tip of the 5f mynx grip vascular closure device did not get into the unknown sheath. There was no reported patient injury. The device is expected to be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004939290-2020-01688 |
| MDR Report Key | 9903152 |
| 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 | 2019-03-18 |
| 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 5F |
| Generic Name | DEVICE, HEMOSTASIS, VASCULAR |
| Product Code | MGB |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-19 |
| Model Number | MX5021 |
| Catalog Number | MX5021 |
| Lot Number | F1907501 |
| 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 |