Catalog Number 0684-00-0567 |
Device Problems
Leak/Splash (1354); Material Rupture (1546)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Injury (2348); Low Oxygen Saturation (2477); Vascular System (Circulation), Impaired (2572); Diminished Pulse Pressure (2606)
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Event Type
Injury
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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.Reference complaint # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the balloon ruptured while inside the patient.The patient experienced a drop in their hemodynamic levels initially, but eventually stabilized.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the balloon ruptured while inside the patient.The patient experienced a drop in their hemodynamic levels initially, but eventually stabilized.
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Manufacturer Narrative
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Additional information - serial number - (b)(4), lot number - 3000084492.The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was a non-maquet device.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 0.3cm from the rear seal measuring 0.038cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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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Search Alerts/Recalls
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