It was reported that some time post port device implant, the patient allegedly experienced palpation.It was further reported that x-ray examination demonstrated catheter break where the distal catheter allegedly broke and the segment migrated to the right atrium.Reportedly, the distal catheter segment and the port body were both removed.There was no patient injury reported post removal.
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It was reported that some time post port device implant, the patient allegedly experienced palpitations.It was further reported that x-ray examination demonstrated catheter break where the distal catheter allegedly broke and the segment migrated to the right atrium.Reportedly, the distal catheter segment and the port body were both removed.There was no patient injury reported post removal.
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Manufacturing review: a manufacturing review were not provided as batch/lot number were not provided.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one powerport isp mri with groshong catheter was received and evaluated.Gross visual observation, microscopic visual observation and functional testing were performed.Observed were multiple punctures and incisions to port septum, both edges of break were jagged and rounded.A complete circumferential break was also noted from the distal end of the cath-lock with both ends of the break in a elliptical shape.This investigation confirms the alleged catheter breakage.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.
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