Model Number CODMAN 3000 |
Device Problems
Obstruction of Flow (2423); Malposition of Device (2616)
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Patient Problems
Vascular Dissection (3160); Thrombosis/Thrombus (4440); Insufficient Information (4580)
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Event Date 12/20/2005 |
Event Type
Injury
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Manufacturer Narrative
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Exact explant date is not known and is estimated.Sufficient information to make a determination of the adverse event is not available at this time.Intera has contacted the physician's institution in order to obtain more information about the nature of the product problem, but has not received additional information at the time of this report.If additional information is received, a supplemental report will be filed.
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Event Description
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Patient called clinical call line in response to device tracking mailing stating that the "pump was blocked and bothering her." patient states pump was removed 4 years ago.
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Event Description
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Additional information was provided from patient's health care provider.The health care provider stated that the patient had a codman 3000 drug delivery pump implanted for hepatic arterial infusion.They stated that five days after implantation, patient had post-surgery abnormal hepatic flow.A diagnostic arteriogram found that the common hepatic artery was dissected and occluded.Vascular dissection and subsequent occlusion/thrombosis may occur due to malposition of the catheter in artery during implant.Vessel thrombosis is a known procedural complication as listed on the labeling of the codman 3000.Heparinized saline was being administered in the pump at the time of the adverse event.Explant date was not provided.
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Manufacturer Narrative
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Updated information based on feedback from the patient's healthcare provider.Blank fields in the mdr form represents unknown information.
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Search Alerts/Recalls
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