FDA Adverse Event
Malfunction
Summary report: N
MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB, PRODUCT CODE: MGB
MDR report key: 4276871
·
Received November 18, 2014
Report
- Report Number
- 3004939290-2014-00974
- Event Type
- Malfunction
- Date Received
- November 18, 2014
- Date of Event
- September 4, 2014
- Report Date
- September 4, 2014
- Manufacturer
- ACCESSCLOSURE, INC.
- Product Code
- MGB
- PMA / PMN Number
- P040044
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PROCESS EVALUATION.
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. A REVIEW OF THE LHR (LOT F1402804) INDICATED THAT THE DEVICE THE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE FOLLOWING INFORMATION WAS REPORTED: BALLOON LOSS OF PRESSURE BEFORE CONTACT WITH TIP OF SHEATH, MANUAL COMPRESSION WAS APPLIED FOR 20 MINUTES. THE PATIENT WAS NOT HOSPITALIZED. STICK LOCATION: COMMON FEMORAL ARTERY. VESSEL SIZE: 6MM. PROCEDURE: PERIPHERAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745377 | MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB, PRODUCT CODE: MGB | MGB, PRODUCT CODE: MGB | MGB | ACCESSCLOSURE, INC. | MX6721 | F1402804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |