Catalog Number 0684-00-0514 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter - (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.Reference complaint (b)(4).Device not returned.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy on an acute myocardial infarction (ami) patient, the iab was unable to advance through the ascending aorta.The iab was replaced and therapy was provided.There was no reported injury to the patient.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.A kink was found on the catheter tubing approximately 51.1cm from the iab tip.A laboratory insertion test was unable to be performed due to the membrane being unfurled.The technician then attempted to insert a laboratory 0.018¿ guide wire through the inner lumen of the returned iab and was successful.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.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.Reference complaint # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy on an acute myocardial infarction (ami) patient, the iab was unable to advance through the ascending aorta.The iab was replaced and therapy was provided.There was no reported injury to the patient.
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Search Alerts/Recalls
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