MAUDE Adverse Event Report: CORDIS SANTA CLARA MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F; LIGHT, WOOD'S, FLUORESCENCE

Model Number MX6721

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

This is one of two products involved with the reported event.The medical device reporting reference number for the other event is 3004939290-2021-02119.The device was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During the use of the mynxgrip vascular closure device (vcd), the physician had difficulty shuttling down and didn't feel the customary distinct stop and click at the bottom of the shuttling.There was no reported patient injury.Manual pressure was used to achieve hemostasis.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no presence of pvd / calcium and scar tissue in the vicinity of the puncture site.The procedure use retrograde approach.Femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.There was confirmation that the balloon was in the artery prior to balloon inflation.Temporary hemostasis was achieve after balloon inflation.After inflating and retracting the balloon of 6f/7f mynxgrip to the arteriotomy, the physician shuttled down the sealant.At that time, doctor didn't feel the customary distinct stop and click at the bottom of the shuttling.The physician deflated the balloon, removed the mynx and the unknown sheath and held pressure.They asked for another mynx and attempted to replicate the same "soft stop" and experienced the same.The patient was fine, recovered well and experienced no adverse effects.At the conclusion of an aif angio, the mynxgrip was retrieved and prepped according to the instructions for use (ifu).The operator was trained to the mynxgrip device.The devices were stored as per labeling and opened in sterile field.The devices will be returned for analysis.No other information was provided.

Manufacturer Narrative

This is one of two products involved with the reported event.The medical device reporting reference number for the other event is 3004939290-2021-02119.During the use of the mynxgrip vascular closure device (vcd), the physician had difficulty shuttling down and didn't feel the customary distinct stop and click at the bottom of the shuttling.There was no reported patient injury.Manual pressure was used to achieve hemostasis.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no presence of pvd / calcium and scar tissue in the vicinity of the puncture site.The procedure used a retrograde approach.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.There was confirmation that the balloon was in the artery prior to balloon inflation.Temporary hemostasis was achieved after balloon inflation.After inflating and retracting the balloon of 6f/7f mynxgrip to the arteriotomy, the physician shuttled down the sealant.At that time, the doctor didn't feel the customary distinct stop and click at the bottom of the shuttling.The physician deflated the balloon, removed the mynx and the unknown sheath and held pressure.They asked for another mynx and attempted to replicate the same "soft stop" and experienced the same.The patient was fine, recovered well and experienced no adverse effects.At the conclusion of an aif angio, the mynxgrip was retrieved and prepped according to the instructions for use (ifu).The operator was trained to the mynxgrip device.The devices were stored as per labeling and opened in sterile field.No other information was provided.The product was not returned for analysis.A product history record (phr) review of lot f2025201 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿shuttle advancement issue¿ could not be confirmed as the product was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Procedural factors, such as failure to shuttle down completely, may have contributed to the reported events.According to the instructions for use (ifu) which is not intended as a mitigation of risk, it states to insert the mynxgrip into the procedural sheath up to the white shaft marker, then inflate the balloon until the black marker is fully visible on the inflation indicator.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.The phr reviews does not suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective action will be taken.

• Brand Name: MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F
• Type of Device: LIGHT, WOOD'S, FLUORESCENCE
• Manufacturer (Section D): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• MDR Report Key: 11683451
• MDR Text Key: 247308288
• Report Number: 3004939290-2021-02120
• Device Sequence Number: 1
• Product Code: GMB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• Combination Product (y/n): N
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: MX6721
• Device Catalogue Number: MX6721
• Device Lot Number: F2025201
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO 6F SHEATH.