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

Model Number N/A

Device Problems Entrapment of Device (1212); Decrease in Pressure (1490); Difficult to Remove (1528); Material Rupture (1546)

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

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed.This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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, closing failed with a 5f mynx control vascular closure device (vcd) because it was ¿coming out of sealant skin¿.There was no reported patient injury.The device will be returned for evaluation.Addendum: product evaluation demonstrated that button two was not completely depressed, approximately 5/6 of its total travel.However, once reset to factory setting, button two was depressed completely and locked in place.The balloon was not able to be retracted completely into the tamp tube.In addition, a leak and a longitudinal tear in the balloon of the returned device was noted.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h10 complaint conclusion: as reported, closing failed with a 5f mynx control vascular closure device (vcd) because it was ¿coming out of sealant skin¿.There was no reported patient injury.Multiple attempts to obtain additional information were made without success.A non-sterile ¿mynx control vcd, 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the device showed that both button 1 and button 2 were depressed with the clock symbol visible in the tension indicator window.It was noted that button 2 was not completely depressed, approximately 5/6 of its total travel.The syringe was received connected to the device for evaluation with the stopcock opened as received.In addition, the balloon was observed not completely retracted into the tamp tube.The sealant was not returned with the device and an unknown cordis procedural sheath was on the device, exposed to blood.The returned device was inspected for damages/anomalies that may have contributed to the reported failure and no damages/anomalies were observed on the returned device.Per functional analysis, button 2 of the returned device was reset to its factory setting, and the balloon¿s inverted tip was straightened out.An inflation/deflation test was simulated, and a leak was found with the balloon of the device.Then, button 2 was depressed completely and locked in place; however, the balloon was not able to be retracting completely into the tamp tube.Visual inspection at high magnification revealed on that the balloon was observed not completely retracted into the tamp tube, and a leak and longitudinal tear in the balloon of the return device was observed.The product history record (phr) review of lot f2224402 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿sealant-inaccurate placement-complete¿ was not confirmed since the sealant was not received with the device.Additionally, the events of ¿balloon-balloon loss of pressure¿ and ¿balloon-retraction jam¿ were noted during analysis of the returned device due to the leakage/rupture noted and the issue with balloon retraction.However, the exact cause of the issues experienced could not be conclusively determined during analysis.Based on the limited information for review, it is not possible to determine what factors may have contributed to events reported.However, access site vessel characteristics (although not provided) and/or concomitant device factors most likely contributed to the rupture noted since a calcified vessel and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause damage to the balloon and the subsequent difficulty retraction difficulty of the balloon.According to the instructions for use (ifu), which is not intended as a mitigation, ¿the safety and effectiveness of the mynx control vcd have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ also stated in the ifu, ¿open the stopcock to deflate the balloon.To ensure complete balloon deflation, wait until air bubbles and fluid have stopped moving through the inflation tubing.Pick up the device handle and realign with the tissue tract.Depress button #2 to pull the deflated balloon into the device.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.Neither the phr review nor the product analysis suggest that the reported failures could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: MYNX CONTROL
• 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 ; 14021 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 17894641
• MDR Text Key: 325261300
• Report Number: 3004939290-2023-03414
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MX5060E
• Device Lot Number: F2224402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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