COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number 8813793009 |
Device Problem
Break (1069)
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Patient Problems
Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164)
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Event Date 11/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the guidewire broke apart at the proximal end and left inside the patient vessel (internal jugular) when it was about to be removed during product insertion.The patient was sent immediately to the operating room to remove the broken guidewire.The catheter was not repaired and there was no leak.Tego was not utilized and there was no luer adapter issue.It was also stated that there was no abnormal condition prior to breaking.It was also mentioned that all pieces were retrieved and x-ray was done to check if all the pieces was removed.The treatment was proceeded and completed.They had to re-insert a new catheter to resolve the issue.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photos noted: the first image depicts the guide wire on a metal table, it's frayed and unraveled.The second image depicts an x-ray, it's not clear of what the image is but there appears to be a hook in the image.Without the physical device all functional evaluations are precluded.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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