MAUDE Adverse Event Report: CORDIS CORPORATION MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	MX6760
Medical Device Problem Codes	Decrease in Pressure (1490); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) ruptured after balloon expansion, while pulling back at an angle aligned with the puncture angle.Another unknown product was opened for hemostasis, and the procedure was completed.There was no reported patient injury.The balloon did not lose pressure during preparation or patient use.The balloon did not lose pressure after being pulled to the arteriotomy.The procedure was treating the superficial femoral artery (sfa) and used an ipsilateral antegrade puncture.The device was prepped and stored per the instructions for use (ifu).A non-cordis sheath introducer was used with the device.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.There was no visible damage to the sheath after removal, and there was no visible damage at the distal end of the sheath after removal.There was no presence of peripheral vascular disease (pvd) or calcium in the vicinity of the puncture site.The vessel diameter was verified to be greater than or equal to 5 mm.There was no vessel tortuosity.The patient was not hospitalized, and hospitalization was not extended as a result of the event.The user was trained on the device.The device was discarded.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.A review of the manufacturing documentation associated with lot j2531401 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: MYNX CONTROL
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 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, CA 95054 ; 7863138372
• MDR Report Key: 25435773
• Report Number: 3004939290-2026-00700
• Device Sequence Number: 16036148
• Product Code: MGB
• UDI-Device Identifier: 10862028000434
• UDI-Public: (01)10862028000434(17)271110(10)J2531401
• 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): Unknown
• 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): 06/12/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MX6760
• Device Lot Number: J2531401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO SHEATH; UNKNOWN CLOSURE DEVICE
• Patient Sex: Unknown