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

Catalog Number MX5060E

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

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

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed.However, it will be submitted within 30 days upon receipt.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, the balloon of a 5f mynx control vascular closure device (vcd) ruptured and the problem was found in the prep.The vessel closure unit was prepared and used in accordance with instructions for use (ifu).Therefore, the product was not available and used other unknown mynx control device and recovered.There was no reported patient injury.There were no visible signs of device/package damage prior to use.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30~45 degrees) of the unknown vascular sheath introducer.The vessel diameter was verified to be greater than 5mm in diameter.The puncture site did not have visible calcium/plaque.There was mild vessel tortuosity.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site.The target femoral site was not previously closed with any closure less than thirty days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.The mynx vcd used in transcatheter arterial chemoembolization (tace) and used a retrograde approach.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured and the problem was found in the prep.The vessel closure unit was prepared and used in accordance with the instructions for use (ifu).Therefore, the product was not available and used other unknown mynx control device and recovered.There was no reported patient injury.There were no visible signs of device/package damage prior to use.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the unknown vascular sheath introducer.The vessel diameter was verified to be greater than 5mm in diameter.The puncture site did not have visible calcium/plaque.There was mild vessel tortuosity.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site.The target femoral site was not previously closed with any closure less than thirty days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.The mynx vcd was used in transcatheter arterial chemoembolization (tace) procedure and used a retrograde approach.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.A non-sterile 5f mynx control vascular closure device (vcd) involved in the reported complaint was returned for investigation.Visual inspection of the device showed that buttons 1 and 2 were not depressed, and the stopcock was found opened.The sealant was present, as expected, in its manufactured position fully covered by the sealant sleeves, which did not show any damage evidence or other type of anomaly.Additionally, the syringe was returned with the device returned; nevertheless, the catheter sheath introducer (csi) used was not.No additional anomalies were observed during this analysis.Functional testing was executed using a cordis lab syringe, and the non-functional condition of the balloon was confirmed as a leak was identified during balloon inflation.The leak was due to a rupture observed on the balloon surface.Per microscopic analysis, a magnified visual analysis of the balloon surface was executed to identify the possible cause of the leak observed during the functional test, and the results showed a longitudinal rupture identified in the body of the balloon.The product history record (phr) review of lot f2312905 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal rupture found could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is not possible to determine what factors may have contributed to the issue reported.However, as this issue was found during preparation of the device, handling factors during prep are possible.According to the ifu during the prepare balloon step, which is not intended as a mitigation, ¿fill locking syringe with 2 to 3 ml of sterile saline, attach to stopcock and draw vacuum.Check luer connector and tighten if necessary.Inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and syringe connector; retighten if necessary.Discard the device if the balloon does not maintain pressure.Check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.¿ neither the phr review, nor the product analysis suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot f2312905 presented no issues during the manufacturing process that can be related to the reported event.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.

• 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 ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 17807145
• MDR Text Key: 324128764
• Report Number: 3004939290-2023-03384
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000441
• UDI-Public: (01)10862028000441(17)250531(10)F2312905
• 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,Followup
• Report Date: 11/28/2023

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 Catalogue Number: MX5060E
• Device Lot Number: F2312905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 10/16/2023; 11/17/2023
• Supplement Dates FDA Received: 11/08/2023; 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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
• Treatment: ANOTHER UNKNOWN MYNX CONTROL.; UNKNOWN SHEATH.