Catalog Number 0684-00-0604 |
Device Problems
Failure to Advance (2524); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/07/2018 |
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 the physician encountered difficulty advancing the intra-aortic balloon (iab) through the sheath during insertion for an acute myocardial infarction (ami) patient.A kink was noted after the attempt.Replaced iab to continue therapy.No patient injury 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 with the one-way valve attached upside down.The sheath was not returned for evaluation.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 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.(b)(4).
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Event Description
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It was reported that the physician encountered difficulty advancing the intra-aortic balloon (iab) through the sheath during insertion for an acute myocardial infarction (ami) patient.A kink was noted after the attempt.Replaced iab to continue therapy.No patient injury reported.
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Manufacturer Narrative
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Correction: the original emdr submission should have reflected the part return.Section d.10.Should have reflected the "returned to manufacture on" date of 08/01/2018.Section h.6 evaluation result code should have reflected code 3233.Evaluation conclusion code should have reflected code 11.Evaluation method code should not have included code 4114.Section h.10 should have had statement indicating product was returned.Complaint # (b)(4).
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Event Description
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It was reported that the physician encountered difficulty advancing the intra-aortic balloon (iab) through the sheath during insertion for an acute myocardial infarction (ami) patient.A kink was noted after the attempt.Replaced iab to continue therapy.No patient injury reported.
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Search Alerts/Recalls
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