FDA Adverse Event
Injury
Summary report: N
MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE
MDR report key: 3945164
·
Received July 18, 2014
Report
- Report Number
- 3004939290-2014-00104
- 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. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.
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 |
|---|---|---|---|---|---|---|---|
| 422952 | MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE | MGB | MGB | ACCESSCLOSURE, INC. | MX6721 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |