Catalog Number C-TQTS-1200 |
Device Problems
Bent (1059); Kinked (1339); Material Twisted/Bent (2981)
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Patient Problem
No Information (3190)
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Event Date 07/12/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
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Event Description
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It was reported during the patient's pneumothorax drainage procedure, it was noted the guide wire became twisted and bent.Another device was used to complete the procedure.Visual inspection of the device along with device imaging identified the stiffener was significantly kinked and twisted near the point of separation.
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Search Alerts/Recalls
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