Catalog Number 0684-00-0604 |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) insertion on an ami (acute myocardial infarction) patient iab membrane became unfurled.Another iab was used to continue therapy.No patient injury was reported.
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Event Description
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It was reported that during intra-aortic balloon (iab) insertion on an ami (acute myocardial infarction) patient iab membrane became unfurled.Another iab was used to continue therapy.No patient injury was reported.
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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.The sheath was not returned for evaluation.The catheter tubing was observed to be oval shaped along its length.This may occur if a vacuum is held with the one-way valve attached for a long period of time on the catheter causing the catheter tubing to lose its round shape.The inner lumen was found to be occluded with dried blood.The occlusion was unable to be cleared.A laboratory insertion test was unable to be performed due to the membrane being unfurled.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.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint # (b)(4), record # (b)(4).
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Search Alerts/Recalls
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