Catalog Number CXI-2.3-14-150-0 |
Device Problem
Split (2537)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/14/2015 |
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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The following information was reported: during an above the knee angioplasty, the physician was inserting the cxi support catheter over another manufacturer's wire.The wire was prolapsed over and the catheter was advanced when the wire sheared/split the distal tip of the catheter upward.The catheter was removed and another device was used to complete the procedure.There were no reported adverse effects to the patient as a result of this product problem.
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Search Alerts/Recalls
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