Catalog Number 0684-00-0475 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/30/2017 |
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 there was a guide wire insertion abstraction during a service visit/demo of the equipment by a company representative.There was no patient involvement and therefore no risk of 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.Complaint # (b)(4).
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Event Description
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It was reported that there was a guide wire insertion abstraction during a service visit/demo of the equipment by a company representative.There was no patient involvement and therefore no risk of injury.
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Manufacturer Narrative
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Iab insertion kit batch was 3000032184, manufactured 6/28/2016, expiration date 6/28/2021.Device evaluation: the product was returned with the membrane loosely folded and traces of blood on the exterior of the catheter with the one-way valve attached.The stylet wire was also returned partially inside the iab lumen.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 able to clear the occlusion and 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.A review of the provided video supports the inner lumen occlusion.The evaluation confirmed the reported problem.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.Complaint # (b)(4).
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Event Description
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It was reported that there was a guide wire insertion abstraction during a service visit/demo of the equipment by a company representative.There was no patient involvement and therefore no risk of injury.
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Search Alerts/Recalls
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