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

Catalog Number MX5021

Device Problem Defective Component (2292)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, proper hemostasis was not achieved after using a 5f mynxgrip vascular closure device (vcd).The device was removed from the patient¿s body.Hemostasis was achieved by manual compression for less than 30 minutes.There was no reported patient injury.The diagnostic 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.The vessel diameter was verified to be greater than or equal to 5mm in diameter.There was little vessel tortuosity.There was no presence of pvd / calcium in the vicinity of the puncture site.The sheath was not kinked/bent upon removal.There was no visible bend/damage in distal end of the balloon shaft after removal.There was no excess force applied during insertion.The device was stored, prepared and used according to the instructions for use (ifu).The user is trained to the device.The device was opened in a sterile field.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.

• 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: 18630461
• MDR Text Key: 334784176
• Report Number: 3004939290-2024-00056
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: 10862028000403
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX5021
• Device Lot Number: F2321206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2023
• 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