Catalog Number 084-00-0475 |
Device Problems
Difficult to Insert (1316); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2019 |
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.Complaint record id # (b)(4).
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Event Description
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It was reported during insertion of the intra-aortic balloon (iab), there was difficulty inserting the balloon through the guide wire and the balloon kinked.The balloon was replaced to start therapy.There was no reported injury to the patient.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded with no visible blood on the catheter.The extender tubing was also returned.Two catheter tubing kinks were observed at approximately 47.2cm & 76.5cm from the iab tip.Additionally, a kink was also observed at the extracorporeal tubing port at the y-fitting at approximately 83.8cm from the iab tip.The technician attempted to insert a laboratory 0.025¿ guidewire through the inner lumen and was able to successfully insert the guidewire.No obstructions were felt.The evaluation confirmed the reported kink in the catheter tubing.We are unable to determine when this may have occurred.The reported difficulty to insert the iab through the guidewire cannot be confirmed by the evaluation.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.Complaint record # (b)(4).
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Event Description
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It was reported during insertion of the intra-aortic balloon (iab), there was difficulty inserting the balloon through the guide wire and the balloon kinked.The balloon was replaced to start therapy.There was no reported injury to the patient.
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Search Alerts/Recalls
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