FDA Adverse Event
Injury
Summary report: N
MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE
MDR report key: 4192515
·
Received October 22, 2014
Report
- Report Number
- 3004939290-2014-00996
- Event Type
- Injury
- Date Received
- October 22, 2014
- Date of Event
- October 7, 2014
- Report Date
- October 8, 2014
- Manufacturer
- ACCESSCLOSURE, INC.
- Product Code
- MGB
- PMA / PMN Number
- P040044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION WAS NOT PERFORMED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE REVIEW OF THE LHR (LOT F1421904) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. (B)(4).
Description of Event or Problem · 1
THE FOLLOWING INFORMATION WAS REPORTED: DEPLOYED MX6721 AND HELD FOR 4 MINUTES. A HEMATOMA THEN FORMED, APPROXIMATELY 5 CM X 5 CM IN SIZE. HELD ADDITIONAL 10 MINUTES OF MANUAL COMPRESSION FOLLOWED BY PLACEMENT OF A FEMOSTOP DEVICE. THE PATIENT WAS NOT HOSPITALIZED. PROCEDURE TYPE: INTERVENTION CORONARY SHEATH SIZE: 6F.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671652 | MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE | MGB | MGB | ACCESSCLOSURE, INC. | MX6721 | F1421904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |