Catalog Number 0684-00-0474 |
Device Problems
Device Sensing Problem (2917); Pressure Problem (3012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.We continue our efforts to follow up with the customer for its return.(b)(4).
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Event Description
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During intra-aortic balloon therapy, it was reported that the arterial pressure signal was not stable, and it showed on the monitor randomly.The cardiologist checked and confirmed that position of the catheter was correct and then changed to another pressure transducer and pump, however the pressure signal was still not stable.The cardiologist replaced the catheter and was able to continue therapy.There was no reported injury to the patient.
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Manufacturer Narrative
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Correction: 'returned to manufacturer on' date should have reflected 12/05/2017 on the initial submission.'evaluation conclusion codes' should have reflected "inconclusive- investigation in progress" instead of 'device not returned' as the investigation was underway as of the last mdr submission.Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.No blood was observed inside the iab catheter.The technician was able to successfully aspirate/flush the inner lumen.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.An evaluation of the product was unable to duplicate the reported problems.The product performed according to specification.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4).
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Event Description
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During intra-aortic balloon therapy, it was reported that the arterial pressure signal was not stable, and it showed on the monitor randomly.The cardiologist checked and confirmed that position of the catheter was correct and then changed to another pressure transducer and pump, however the pressure signal was still not stable.The cardiologist replaced the catheter and was able to continue therapy.There was no reported injury to the patient.
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Search Alerts/Recalls
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