MAUDE Adverse Event Report: CARDINAL HEALTH SANTA CLARA MYNXGRIP; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number UNKMYNXGRIP

Device Problem Separation Failure (2547)

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

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the sealant of a mynxgrip vascular closure device (vcd) was stuck in the tamp tube.There was no reported patient injury.Additional information was requested but not provided.The device was not returned for delivery as previously expected.

Manufacturer Narrative

As reported, the sealant of an unknown mynxgrip vascular closure device (vcd) was stuck in the tamp tube.There was no reported patient injury.Additional information was requested but not provided.The device was not returned for analysis as previously expected.The reported event of ¿sealant-sealant stuck to device components¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue reported could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the sealant becoming stuck to the advancer (tamp) tube.However, handling factors (such as over-tamping) are possible.According to the mynxgrip instructions for use (ifu), which is not intended as a mitigation, ¿while maintaining light tension to keep the balloon abutted against the arteriotomy or venotomy, immediately grasp the advancer tube at the skin and gently advance until the single marker is fully visible and then hold in place for up to 30 seconds.¿ if the user over-tamps by pushing the tamping tube too far into the hydrogel sealant, the grip tip of the sealant may adhere to the advancer tube and the sealant may follow the advancer tube out of the tissue tract during removal.Based on the information available for review, there is no indication that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: MYNXGRIP
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 18028414
• MDR Text Key: 327647200
• Report Number: 3004939290-2023-03448
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKMYNXGRIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.