Catalog Number CS-15402-E |
Device Problem
Material Rupture (1546)
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Patient Problems
Death (1802); Device Embedded In Tissue or Plaque (3165)
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Event Date 06/26/2019 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).Additional information received from user facility: cause of death not specified and not associated with this event.The customer reports the death was not associated with the device.A medical intervention was required, the issue with the device was not associated with this event.The event was reported by a healthcare pharmacist since the event reported as a non-serious adverse.
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Event Description
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The customer reports: during the insertion of the catheter it is notice that the swg (spring wire guide) ruptures, leaving metallic filament embedded in the patient.Rx is performed and is evidence a possible metallic piece in the cervical zone.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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The customer reports: during the insertion of the catheter it is notice that the swg (spring wire guide) ruptures, leaving metallic filament embedded in the patient.Rx is performed and is evidence a possible metallic piece in the cervical zone.
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Search Alerts/Recalls
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