Model Number MICTI50041M |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problems
Extravasation (1842); Swelling/ Edema (4577)
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Event Date 11/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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During scheduled irrigation with saline solution of the port, swelling of the subcutaneous tissue appears due to suspected extravasation.After the x-ray verification of the integrity of the catheter in the thoracic and brachial tract, the device was removed with almost total breakage detected 2 cm from the reservoir in the subcutaneous section of the catheter with another small lesion 0.5 cm from the previous one.Device was implanted (b)(6) 2021.No problems with the device during previous administrations of anti-tumor therapy.Use suspended for more than one year prior to this event.
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Manufacturer Narrative
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The 5f dignity port was returned with the lumen and lock attached.Visual inspection revealed a kink and a tear 1.5 cm distal to the lock, with another tear 1 cm from the first tear.Clotted blood was noted in the lumen forming obstructions.The blood in the lumen could not be removed during decontamination or by inserting a guidewire through the distal tip of the lumen.Under magnification it appears the lumen burst in both tear locations.The device was implanted for >2 years with no reported issues and use of the device was suspended for more than one year prior to this event.There is no indication if the device was maintained properly during that year of not being used.The clotted blood in the lumen could be indicative that the device was not maintained properly.Excessive external pressure applied to an obstructed lumen may be a contributing cause for this type of failure.Another possible contributing factor is "pinch-off" due to the location of the tears.A definitive root cause could not be determined; however, it is unlikely related to manufacturing.
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Search Alerts/Recalls
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