Catalog Number 0684-00-0575 |
Device Problems
Difficult to Insert (1316); Physical Resistance (2578)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/14/2017 |
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 while using a 23cm 8fr cordis sheath, into right groin, the intra-aortic balloon (iab) catheter was advanced over the wire, but had resistance and could not be inserted fully.The iab was prepped and pulled negative 2 times before reaching the patient.Dr.Did not feel comfortable using this balloon, and replaced with a new iab.There was no injury or harm to the patient.
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Manufacturer Narrative
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The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
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Event Description
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It was reported that while using a 23cm 8fr cordis sheath, into right groin, the intra-aortic balloon (iab) catheter was advanced over the wire, but had resistance and could not be inserted fully.The iab was prepped and pulled negative 2 times before reaching the patient.Dr.Did not feel comfortable using this balloon, and replaced with a new iab.There was no injury or harm to the patient.
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Manufacturer Narrative
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Additional info: reporter's phone number is (b)(6), it was inadvertently not submitted in initial mdr report.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter with the one-way valve attached.The sheath was not returned for evaluation.The catheter tubing was observed to be flattened 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.Two kinks were found on the catheter tubing near the y-fitting approximately 75.2cm and 76.2cm from the iab tip.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 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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It was reported that while using a 23cm 8fr competitor's sheath, into right groin, the intra-aortic balloon (iab) catheter was advanced over the wire, but had resistance and could not be inserted fully.The iab was prepped and pulled negative 2 times before reaching the patient.Dr.Did not feel comfortable using this balloon, and replaced with a new iab.There was no injury or harm to the patient.
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Search Alerts/Recalls
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