Catalog Number AA-10611-1 |
Device Problems
Entrapment of Device (1212); Material Separation (1562)
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Patient Problem
Vessel Or Plaque, Device Embedded In (1204)
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Event Date 08/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported "uncomplicated puncture of the radial artery.Difficulties to insert the sheath through the skin.Consequently, sending off the tip after the incision resistance to push the sheath.After pushing the sheath guidewire was broke." it was reported that the device was removed.Another device was used via a different entrance.It was also reported that the patient did require an intervention to remove the piece of the guidewire that broke off."the surgeon cut the skin and vessel open to remove the device".Patient current condition reported as fine.There was no report of patient death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of swg damaged/separated is confirmed.The swg was returned with significant unraveling and damage.The root cause of the unraveling/damaged swg is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.Other remarks: additional information was obtained from the healthcare provider.It was reported that the device was removed in its entirety.A new device was placed.The patient outcome reported as okay and the procedure was a success in the end.There was no harm done.
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Event Description
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It was reported "uncomplicated puncture of the radial artery.Difficulties to insert the sheath through the skin.Consequently, sending off the tip after the incision resistance to push the sheath.After pushing the sheath guidewire was broke." it was reported that the device was removed.Another device was used via a different entrance.It was also reported that the patient did require an intervention to remove the piece of the guidewire that broke off."the surgeon cut the skin and vessel open to remove the device".Patient current condition reported as fine.There was no report of patient death.
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Search Alerts/Recalls
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