Model Number 8700-0671 |
Device Problems
Material Separation (1562); Device Issue (2379)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The zoll catheter in complaint was returned to zoll on 04/15/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
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Event Description
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It was reported that the physician had difficulties inserting the zoll solex 3 lumen catheter, in the patient's vena jugular vein.The physician switch to the zoll cool line catheter.No issues reported.When the solex catheter was examined by the physician, it was noted that the spiral balloon portion was detached from the catheter.There was no patient sequelae reported.No additional information provided.
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Manufacturer Narrative
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Two solex catheters (s/n (b)(4)) were returned to zoll (b)(4) on 04/15/2016 for evaluation.A visual inspection found no visual discrepancies or issues.All lumens flushed as intended.No leaks were noticed during flushing the catheter.The spiral portion was not damaged or detached.Following the test, all balloons deflated successfully without any issues.Device history record was reviewed for balloon bonding lot no 56974 found no nonconformities with the lot.Evaluation of the returned device did not confirm the customer reported issue.The probable cause for the customer reported experience was due to operational context, including, but not limited to patient's skin condition.There was no patient injury or death attributable to this complaint.
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Search Alerts/Recalls
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