MAUDE Adverse Event Report: Cordis US Corp. MYNX CONTROL VENOUS; Device, Hemostasis, Vascular

Catalog Number	MX61260
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, two 6f mynx control venous vascular closure devices (vcd) were used.The first mynx, the balloon ruptured during prep.The second mynx, the sheath was cracked near the balloon.There was no reported injury to the patient.Other procedural details were requested but were not provided.The devices will be returned for evaluation.
Additional Manufacturer Narrative
As reported, two 6f mynx control venous vascular closure devices (vcd) were used.The first mynx, the balloon ruptured during prep.The second mynx, the sheath was cracked near the balloon.The product was not returned for analysis.A review of the manufacturing documentation associated with lot f2609701 presented no issues during the manufacturing process that can be related to the reported event.The reported event of ¿balloon-balloon loss of pressure¿ could not be observed as the device was not returned for analysis.The exact cause of the issue experienced could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to balloon rupture reported.However, access site vessel characteristics (which was not provided) and/or concomitant device factors are likely since calcification at the access site and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause damage to the balloon.According to the mynx control venous instructions for use (ifu), which is not intended as a mitigation, ¿the safety and effectiveness of the mynx control venous vcd 6f-12f 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 during product preparation, ¿confirm via imaging prior to using the mynx control venous vcd 6f-12f: common femoral vein single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.Neither the product history review, nor the information available for review suggests 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.

• Brand Name: MYNX CONTROL VENOUS
• Common Device Name: Device, Hemostasis, Vascular
• Manufacturer (Section D): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054
• MDR Report Key: 50568655
• Report Number: 3004939290-2026-01185
• Device Sequence Number: 10483269
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17)280407(10)F2609701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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 Catalogue Number: MX61260
• Device Lot Number: F2609701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown