Catalog Number 0684-00-0497 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/19/2018 |
Event Type
malfunction
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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 during intra-aortic balloon (iab) insertion, the guidewire was inserted into the femoral artery, but the iab would not advance over the wire.The iab was removed and the perfusionist tried to flush the iab, but was unable to.A new iab was inserted successfully.There was no reported injury to the patient.
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Event Description
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It was reported that during intra-aortic balloon (iab) insertion, the guidewire was inserted into the femoral artery, but the iab would not advance over the wire.The iab was removed and the perfusionist tried to flush the iab, but was unable to.A new iab was inserted successfully.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 and blood on the exterior of the catheter with the one-way valve attached.One kink was found on the inner lumen and catheter tubing approximately 76.5cm from the iab tip.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen was kinked and occluded.The technician was able to clear the occlusion, however evidence of dried blood was observed at the tip of the guide wire.The condition of the iab as received indicated an occlusion and a kink in the inner lumen and catheter tubing.The evaluation confirmed the reported problems.The evaluation confirmed the reported problems.Blood clotting within the inner lumen will seal the passage.It is difficult to determine when the occlusion occurs, however, if this occurs during the procedure it will be impossible to flush or aspirate through the inner lumen.It can also cause poor or no pressure waveform and guide wire insertion difficulty.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.(b)(4).
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Search Alerts/Recalls
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