Model Number PUMP 380 14F LT CMR SET (US) |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Event Description
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The user facility reported a 79-year-old male noted as high risk percutaneous coronary intervention was implanted with an impella device for mechanical circulatory support.The cp support ongoing for a patient via the 14fr sheath.The patient had curvature of the aortic arch.The pump kinked and had low flows.The kinked pump was not replaced.The support remained til explant at 46minutes after hrpci.
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Manufacturer Narrative
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The impella device was not received from the customer and therefore, an evaluation of the device was not possible.Upon investigation closure, a supplemental mdr will be filed.
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Manufacturer Narrative
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The investigation into the product damage (cannula kink) issue has been completed since the original report was submitted.The device was not returned for investigation.However, data log review and clinical information provided determined there were low pump flow and saturated flow.The root cause of the low pump flow issue was patient condition related since cannula kinking due to patient anatomy.The cause of the saturated flow issue was most likely biomaterial per log review.
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Search Alerts/Recalls
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