FDA Adverse Event
Injury
Summary report: N
MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE
MDR report key: 3945163
·
Received July 18, 2014
Report
- Report Number
- 3004939290-2014-00102
- Event Type
- Injury
- Date Received
- July 18, 2014
- Report Date
- July 7, 2014
- Manufacturer
- ACCESSCLOSURE, INC.
- Product Code
- MGB
- PMA / PMN Number
- P040044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1406401) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.
Description of Event or Problem · 1
THE ACI REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE DEPLOYER SELECTED A MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE TO CLOSE THE ACCESS SITE. A HEMATOMA WAS NOTED WHICH WAS DESCRIBED TO BE "SIGNIFICANTLY" LARGER THAN 5 CM IN SIZE. THE PATIENT REQUIRED BETWEEN 10-15 MINUTES OF MANUAL COMPRESSION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422419 | MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE | MGB | MGB | ACCESSCLOSURE, INC. | MX6721 | F1406401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |