Catalog Number 0684-00-0549-02 |
Device Problems
Difficult to Flush (1251); Difficult to Advance (2920)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/11/2018 |
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 during iab insertion on an acs (acute coronary syndrome) patient, the inner lumen was hard to flush.The guidewire was difficult to advance.A manufacturer's sheath was used.The iab was replaced to continue therapy.No patient injury was reported.
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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 iab insertion on an acs(acute coronary syndrome) patient, the inner lumen was hard to flush.The guidewire was difficult to advance.A manufacturer's sheath was used.The iab was replaced to continue therapy.No patient injury was reported.
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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.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 occluded.The technician was unable 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 in the inner lumen.We are unable to determine how this may have occurred.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 lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint # (b)(4), record # (b)(4).
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Event Description
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It was reported that during iab insertion on an acs(acute coronary syndrome) patient, the inner lumen was hard to flush.The guidewire was difficult to advance.A manufacturer's sheath was used.The iab was replaced to continue therapy.No patient injury was reported.
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Manufacturer Narrative
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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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Event Description
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It was reported that during iab insertion on an acs(acute coronary syndrome) patient, the inner lumen was hard to flush.The guidewire was difficult to advance.A manufacturer's sheath was used.The iab was replaced to continue therapy.No patient injury was reported.
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Search Alerts/Recalls
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