Model Number H74912044106870 |
Device Problems
Break (1069); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2021 |
Event Type
malfunction
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Event Description
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It was reported the guidewire became caught on the stent catheter.A 10mm x 68mm venous self-expanding wallstent and a 0.035 x 180 cm amplatz superstiff straight tip guidewire were selected for use in a recanalization procedure.The wallstent was loaded onto the amplatz guidewire.After the wire was placed within the stent delivery system, a burr was observed on the guidewire.The burr snagged and then damaged the stent catheter.New devices were used to complete the procedure.There were no patient complications.
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Event Description
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It was reported the guidewire became caught on the deployed stent.A 10mm x 68mm venous self-expanding wallstent and a 0.035 x 180 cm amplatz superstiff straight tip guidewire were selected for use in a recanalization procedure.The wallstent was loaded onto the amplatz guidewire.After the wire was placed within the stent delivery system, a burr was observed on the guidewire.The burr snagged and then damaged the stent catheter.New devices were used to complete the procedure.There were no patient complications.
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Manufacturer Narrative
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Device eval by mfr: the venous wallstent was received with the stent over reconstrained on the device and the tip withdrawn into the shaft.A visual and tactile examination found the blue outer shaft of the device to be separated exposing the black inner shaft at approximately 25mm distal of the main t-valve.The shaft of the device was also found to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.The stent of the device could not be deployed for examination due to severe shaft damage.
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Search Alerts/Recalls
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