|
Catalog Number MX6760E |
Device Problems
Decrease in Pressure (1490); Material Rupture (1546)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/18/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 6/7f mynx control vascular closure device (vcd) burst during prep.Therefore, the product was not available and manual compression was performed for twenty minutes and recovered.There was no reported patient injury.There were no visible signs of device/package damage prior to use.The mynx control vessel closure unit was prepared and used in accordance with instructions for use (ifu) instructions.The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 6f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd used in transfemoral cerebral angiography (tfca) with a retrograde approach.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
|
|
Event Description
|
As reported, the sealant sleeve of a 6/7f mynx control vascular closure device (vcd) was broken and did not enter the 6f non-cordis sheath.Therefore, the product was not available and manual compression was performed for twenty minutes and recovered.There was no reported patient injury.There were no visible signs of device/package damage prior to use.The mynx control vessel closure unit was prepared and used in accordance with instructions for use (ifu) instructions.The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 6f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd used in transfemoral cerebral angiography (tfca) with a retrograde approach.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: per product evaluation, the cartridge assembly presents a kinked condition.
|
|
Manufacturer Narrative
|
Due to a mix up of information, this complaint was inadvertently coded with a reportable event; however, upon further review a reportable event did not occur with this product and is no longer reportable under the fda guidelines.Therefore, this event will be unreported and no further reports will be forthcoming.
|
|
Search Alerts/Recalls
|
|
|