Catalog Number IAB-04830-U |
Device Problems
Entrapment of Device (1212); Fluid/Blood Leak (1250)
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Patient Problems
Ischemia (1942); Thrombus (2101); Vascular System (Circulation), Impaired (2572)
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Event Date 10/31/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that blood was in the helium circuit of the balloon.It was impossible to remove the balloon which was locked inside the left common femoral artery.The clinical consequence was ischemia of the lower left limb.Emergency surgery was performed to remove the balloon and repair the left common femoral artery and fogarty thrombectomy by the superficial femoral downstream.The staff noticed that the balloon contained very hard blood clots that prevented the deflation of the balloon.
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Manufacturer Narrative
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(b)(4).Additional information received the iab therapy was in use for 24 hours prior the nurse noticing the blood.The pump was stopped and blood did not enter it.Evaluation: teleflex received the device for analysis.A manual pump was attached to the iab upon receipt.The short driveline tubing was retro fitted to connect the manual pump to the iab with a standardized connector.The connector that allows the driveline tubing to connect to the iab short driveline tubing was not returned with the device.The one-way valve was not returned for evaluation.Hard blood clots were noted within the bladder membrane upon return.The bladder appeared torn approximately 13.0cm from the distal tip of the catheter.The bladder thickness was measured and was within specification.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint and determined that the occurrence rate is within acceptable risk limits.See other remarks section.Other remarks: conclusion: the reported complaint of blood in the helium pathway is confirmed based on visual inspection of the device.Three cuts consistent with contact from a sharp object were found on the bladder membrane allowing blood to enter the helium pathway.No abrasions were noted.The root cause of the damage is undetermined.
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Event Description
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It was reported that blood was in the helium circuit of the balloon.It was impossible to remove the balloon which was locked inside the left common femoral artery.The clinical consequence was ischemia of the lower left limb.Emergency surgery was performed to remove the balloon and repair the left common femoral artery and fogarty thrombectomy by the superficial femoral downstream.The staff noticed that the balloon contained very hard blood clots that prevented the deflation of the balloon.
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Search Alerts/Recalls
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