Model Number AB35W06120135 |
Device Problems
Nonstandard Device (1420); Device Markings/Labelling Problem (2911)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/20/2014 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.(b)(4).
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Event Description
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It was reported that during the procedure the catheter shaft seemed too short.They then double checked the packaging which stated it was a 6mm x 120mm x 135mm.The device was actually a 6mm x 40mm x 80mm.Case was completed with a 6mm x 100mm balloon.Evaluation summary: the evercross 0.035in otw pta dilation catheter was received for evaluation without any ancillary devices or cine images from the procedure.The device was returned packed in its pouch and shelf carton.Examination of the shelf and pouch labels matches the labels in the shop-floor paperwork for lot number 9855406 work order.The evercross device was covered with sanguine material.The balloon was returned without its shipping hoop and balloon chamber protector.The balloon chamber is in a pre-inflation profile: tightly wrapped or winged.The strain relief indicates that it is a 6mm by 40mm balloon catheter.The distance between the balloon radiopaque markers is consistent with a 40mm balloon.The overall length of the device is approximately 90cm from proximal hub to distal tip.
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Search Alerts/Recalls
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