Catalog Number 0684-00-0513 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/30/2018 |
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 in ami(acute myocardial infarction) patient that the iab catheter was unable to advance through the sheath.The iab was replaced to continue therapy.There was no patient injury was reported.
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Manufacturer Narrative
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Correction: lot # changed from: 3000043012 to:3000041412.Serial # added.Expiration date changed from: 01/03/2020 to:12/05/2019.Describe event or problem: removed "was".Manufacture date changed from: 01/03/2017 to: 12/05/2016.Device evaluation: the product was returned with the membrane completely unfolded and traces of blood found on the exterior of the catheter with the one-way valve attached.The guide wire was also returned.The sheath was not returned for evaluation.The returned guide wire was found to be bent in two places near the proximal end and could not be used for testing.The one-way valve was vacuum tested and it held vacuum.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, extracorporeal and extender 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 non-conformances were found that are considered to be related to the event.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) insertion in ami (acute myocardial infarction) patient that the iab catheter was unable to advance through the sheath.The iab was replaced to continue therapy.There was no patient injury reported.
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Search Alerts/Recalls
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