MYNXGRIP
Report
- Report Number
- 3004939290-2023-02902
- Event Type
- Malfunction
- Date Received
- February 13, 2023
- Date of Event
- January 13, 2023
- Report Date
- June 5, 2023
- Manufacturer
- CARDINAL HEALTH SANTA CLARA
- Product Code
- MGB
- UDI-DI
- 10862028000403
- PMA / PMN Number
- P040044
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A PRODUCT HISTORY REVIEW IS EXPECTED BUT NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS REPORT IS RELATED TO MDR: 3004939290-2023-02889.
THIS REPORT IS RELATED TO MDR REPORT NUMBER #3004939290-2023-02889. AS REPORTED THE PLUG OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) DID NOT COME LOOSE FROM THE SYSTEM, AND WAS STUCK IN THE SLEEVE. THIS HAPPENED TWICE IN THIS CASE, AS ANOTHER MYNX WAS TAKEN OUT OF THE PACKAGING FOR TESTING, BUT NOT USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE IFU. THE DEVICE WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE. THE DEPLOYER WAS MYNX CERTIFIED. THE ADVANCER TUBE WAS ENGAGED AND VISIBLE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT NOT PROVIDED. THE PROCEDURAL DEVICE IS BEING RETURNED FOR EVALUATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F2227402 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿SEALANT FAILURE TO DEPLOY¿ WAS NOT CONFIRMED DURING ANALYSIS OF THE RETURNED DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. PATIENT OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, USERS ARE INSTRUCTED NOT TO USE THE DEVICE IF IT APPEARS DAMAGED IN ANY WAY. NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.
A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT F2227402 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED THE PLUG OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) DID NOT COME LOOSE FROM THE SYSTEM, AND WAS STUCK IN THE SLEEVE. THIS HAPPENED TWICE IN THIS CASE, AS ANOTHER MYNX WAS TAKEN OUT OF THE PACKAGING FOR TESTING, BUT NOT USED ON PATIENTS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE IFU. THE DEVICE WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE. THE DEPLOYER WAS MYNX CERTIFIED. THE ADVANCER TUBE WAS ENGAGED AND VISIBLE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT NOT PROVIDED. THE DEVICE IS BEING RETURNED FOR EVALUATION.
AS REPORTED THE PLUG OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) DID NOT COME LOOSE FROM THE SYSTEM, AND WAS STUCK IN THE SLEEVE. THIS HAPPENED TWICE IN THIS CASE, AS ANOTHER MYNX WAS TAKEN OUT OF THE PACKAGING FOR TESTING, BUT NOT USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE IFU. THE DEVICE WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE. THE DEPLOYER WAS MYNX CERTIFIED. THE ADVANCER TUBE WAS ENGAGED AND VISIBLE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT NOT PROVIDED. THE PROCEDURAL DEVICE IS BEING RETURNED FOR EVALUATION. THE DEVICE USED FOR TESTING IS NOT BEING RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2229223 | MYNXGRIP | DEVICE, HEMOSTASIS, VASCULAR | MGB | CARDINAL HEALTH SANTA CLARA | N/A | F2227402 | 10862028000403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |