C.R. BARD, INC. (BASD) -3006260740 POWER PORT ISP M.R.I., 8FR GROSHONG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 4808570J |
Device Problem
Difficult to Advance (2920)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 12/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong products that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong products are identified.Device not returned.
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Event Description
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It was reported that during port placement procedure via left internal jugular vein, the guidewire allegedly perforated vascular wall of the brachiocephalic vein.It was further reported that it was allegedly difficult to be advanced and the physician applied strong force.Reportedly, dilator was advanced over the guidewire without noticing the perforation, and it allegedly perforated the same site.The patient current status is unknown.
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Search Alerts/Recalls
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