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Catalog Number MX5060E |
Device Problems
Decrease in Pressure (1490); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported, the balloon of a 5f mynx control vascular closure device (vcd) burst during prep.Therefore, the product wasn¿t available and manual compression was performed for 20 minutes and the patient recovered.There was no reported patient injury.The device was used in a transfemoral cerebral angioplasty (tfca) procedure.There were no visible signs of device/package damage prior to use.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.The device was prepared and used in accordance with the instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
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Manufacturer Narrative
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After further review of additional information received the following sections have been updated accordingly: d9, g3, g6, h1, h2, h3.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.
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Search Alerts/Recalls
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